Model N118, Serial numbers: 559134, 559655, 560551, 561872, 561997, 562290, 562354, 562357, 563022, 563129, 564231, 564257, 564276 and 564489 and  Model N119, Serial numbers: 002009, 005588, 005947, 006015, 008336, 008383, 011748, 016012, 016410, 018621, 019026, 019284, 024632, 024670, 024705, 025094, 025446, 026128, 026211, 026713, 026935, 028047, 032967, 033881, 035717, 035791, 035824, 037277, 044056, 046565 and 046574.

Cardiovascular Devices

3

Yes

U.S. Distribution only (states of AZ, CA, CT, FL, GA, IA, IL, KY, MD, MO, NH, NJ, NY, OH, PA, SC, TN, TX, WI, and Washington D.C.) and Puerto Rico.

Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, Models N118 and N119. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 66112-5798, USA. || The product is indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. COGNIS devices also provide bi-ventricular pacing.

Model E102, Serial numbers: 002673, 003415, 004433, 004856, 005108, 005677, 006215, 006309, 006321, 006641, 006766, 006771, 006787, 006799, 006815, 006819, 006937, 006946, 006960, 006969, 006970, 006979, 006985, 007011, 007051, 007125, 007219, 007706, 007713, 007730, 008173, 008459, 008541, 008617, 008759, 008822, 008832, 008972, 008998, 009055, 009068, 009079, 009102, 009117, 009151, 009182, 009224, 009345, 009379, 009723, 010141, 010167 and 010186 and   Model E110, Serial numbers: 002872, 003458, 003681, 004229, 004300, 004979, 004989, 006517, 006935, 007106, 008280, 008356, 008591, 009837, 009865, 010026, 010341, 010365, 010393, 010413, 010508, 010510, 010533, 010555, 010581, 010596, 010694, 011538, 011578, 012363, 012373, 012571, 012712, 012785, 012809, 013015, 013024, 013759, 013885, 111500, 111570, 111584, 111599, 111610, 111661, 111664, 111700, 111703, 112637, 112716 and 113694.

Cardiovascular Devices

3

Yes

U.S. Distribution only (states of AZ, CA, CT, FL, GA, IA, IL, KY, MD, MO, NH, NJ, NY, OH, PA, SC, TN, TX, WI, and Washington D.C.) and Puerto Rico.

Boston Scientific TELIGEN, Implantable Cardiac Defibrillator, Models E102 and E110. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 66112-5798, USA. || The product is indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. COGNIS devices also provide bi-ventricular pacing.

Serial number: PUL450634H.

Cardiovascular Devices

3

Yes

Nationwide Distribution-- (states of IA and NJ).

Medtronic Virtuoso DR, Model D154AWG, Dual Chamber implantable cardioverter defibrillator with atrial and ventricular therapies. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. || This device is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias in patients with NYHA functional Class II/III heart failure. In addition, the device is indicated for use in the above patients with atrial tachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias.

Serial number: PUN421618H.

Cardiovascular Devices

3

Yes

Nationwide Distribution-- (states of IA and NJ).

Medtronic Virtuoso VR, Model D154VWC, Single Chamber implantable cardioverter defibrillator with atrial therapies. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. || This device is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias in patients with NYHA functional Class II/III heart failure.

Lot Number: 9011951

Cardiovascular Devices

3

Yes

Nationwide: GA, NY, IN, LA, MA and PA

Xact 9 mm x 20 mm x 136 cm (Part Number 82089-01) || The Xact Carotid Stent System, used in conjunction with Emboshield Embolic Protection System is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease.

Lot Number: 9020551

Cardiovascular Devices

3

Yes

Nationwide: GA, NY, IN, LA, MA and PA

Xact 10 mm x 20 mm x 136 cm (Part Number 82099-01) || The Xact Carotid Stent System, used in conjunction with Emboshield Embolic Protection System is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease.

Lot Number: 9081851

Cardiovascular Devices

3

Yes

Nationwide Distribution.

RX ACCULINK Carotid Stent System, 10x40 mm, Product Number: 1011344-40, Lot Number: 9081851. || Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.

Serial Numbers: AD5001 through AD5496, except AD5006 and AD5018.

Cardiovascular Devices

3

Yes

Worldwide Distribution -- United States, Australia, Brazil, China, Hong Kong, Japan, Mexico and Germany.

Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000. Manufactured by Abiomed, Inc. Danvers, MA. || Intended to provide complete short-term support of the left and/or right sides of the heart to patients suffering from potentially reversible ventricular dysfunction.

Product Code: M002004910580; Lot # 12633379, Exp: 4/2012

Cardiovascular Devices

2

Yes

Product was distributed to hospitals in TX, TN, CT, AR, AZ as well as to Austria and France.

EXXCEL Soft Standard Wall EPTFE Vascular Graft; || D:8 mm: L: 50 mm straight || Maquet Cardiovascular LLS, 45 Barbour Pond Drive, Wayne, NJ 07470

Serial Number: 40246657, Lot number: 09M03.

Cardiovascular Devices

2

Yes

Nationwide Distribution - Arizona.

InterGard Knitted Collagen Coated Vascular prostheses, Catalog number: IGK1206. InterVascular SAS, France. || Indicated for surgical repair, bypass or replacement of arteries in the treatment of aneurysmal and occlusive disease of the abdominal aorta, visceral arteries, and peripheral arteries.

All EnRhythm pacemakers

Cardiovascular Devices

3

Yes

All States in the USA including Guam, Puerto Rico and DC. OUS: Customers in the following countries: Andorra, Argentina, Aruba, Australia, Austria, Bangladesh, Belarus, Belgium, Brazil, Brunei, Darussalam, Canada, Cayman Islands, Chile, China, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Vatican City, Venezuela, Viet Nam, Virgin Islands

Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. The EnRhythm pacing system is an implantable medical device that monitors, detects, and treats atrial tachyarrhythmia episodes. It also provides bradycardia pacing and monitoring of ventricular tachycardia (VT) episodes. Manufactured at: Juncos, Puerto Rico, USA. Medtronic, Inc., Minneapolis, MN 55432 USA.

Cardiovascular Devices

3

Yes

All States in continental USA including DC except Alaska. OUS: Algeria, Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Belgium, Bolivia, Bosnia And Herzegovina, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, El Salvador, Finland, France, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Vatican City, Venezuela, and Yemen.

Medtronic, Sutureless, unipolar, myocardial, screw-in pacing lead, 5071-15, 5071-25, 5071-35 & 5071-53, Medtronic, Inc., Minneapolis, MN 55432, Manufactured in: Villalba, Puerto Rico.

Product Reference Serial Number Lot number IGW1206 40199297 09J17 IGK2412 40200277 09J17  40200412 09J17 IGK0018-40 40200310 09J17 IGW0008-30 40199072 09J17

Cardiovascular Devices

2

Yes

US Distribution went to one distributor in Arizona. Also Chile, France, Germany, Hong Kong, Poland and Turkey.

InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; || InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.

Model E102, serial numbers: 010347, 241131, 242141, 242171, 242431, 242505, 242543, 242657, 242708, 243839, 243965, 244071, 244521, 244580, 244921, 244928, 245000, 245295, 245479, 245519, 245578, 245583, 245619, 245655, 246303, 246369, 246384, 246395, 246396, 246481, 246498, 246502, 246508, 246511, 246516, 246542, 246546, 246548, 246558, 246561, 246592, 246609, 246618, 246653, 246752, 246756, 246888, 246959, 247313, 247342, 247346, 247417, 247452, 247481, 247614, 247618, 247632, 247663, 247687, 247779, 247788, 247893, 248102, 248353, 248557, 248587, 248622, 248630, 248635, 248670, 248805, 248916, 248933, 248968, 248997, 249064, 249083, 249087, 249130, 249370, 249398, 249454, 249468, 249496, 249533, 249534, 249537, 249538, 249556, 249594, 249602, 249627, 249629, 249631, 249650, 249669, 249727, 249751, 249753, 249777, 249868, 249882, 249925, 249934, 249943, 249954, 249960, 250007, 250020, 250031, 250049, 250067, 250089, 250114, 250120, 250121, 250135, 250139, 250147, 250159, 250191, 250194, 250197, 250206, 250230, 250233, 250234, 250246, 250258, 250279, 250289, 250290, 250306, 250324, 250328, 250330, 250337, 250349, 250368, 250382, 250387, 250400, 250421, 250422, 250424, 250431, 250436, 250482, 250497, 250498, 250518, 250538, 250541, 250544, 250553, 250579, 250585, 250596, 250597, 250599, 250602, 250641, 250660, 250670, 250675, 250679, 250684, 250719, 250772, 250781, 250788, 250790, 250794, 250802, 250805, 250811, 250844, 250848, 250859, 250869, 250873, 250891, 250900, 250929, 250979, 251003, 251005, 251024, 251030, 251041, 251065, 251090, 251119, 251122, 251133, 251140, 251146, 251156, 251157, 251167, 251177, 251184, 251211, 251212, 251215, 251226, 251228, 251233, 251239, 251247, 251248, 251255, 251261, 251277, 251280, 251302, 251312, 251316, 251325, 251328, 251442, 251447, 251459, 251500, 251560, 251563, 251565, 251567, 251568, 251573, 251591, 251594, 251600, 251603, 251614, 251616, 251621, 251623, 251624, 251625, 251626, 251632, 251634, 251638, 251640, 251643, 251650, 251654, 251655, 251656, 251658, 251674, 251675, 251681, 251687, 251689, 251715, 251779, 251789, 251797, 251805, 251806, 251861, 251873, 251874, 251890, 251891, 251893, 251896, 251904, 251928, 251933, 251954, 252013, 252034, 252519, 252521, 252548, 252553, 252554, 252569, 252570, 252573, 252600, 252615, 252621, 252623, 252647, 252661, 252672, 252694, 252718, 252719, 252736, 252739, 252744, 252745, 252754, 252757, 252769, 252819, 252820, 252825, 252835, 252863, 252870, 252926, 252928, 252934, 252954, 252976, 252983, 253000, 253011, 253012, 253015, 253019, 253025, 253073, 253105, 253111, 253121, 253122, 253137, 253170, 253174, 253184, 253189, 253198, 253243, 253249, 253269, 253280, 253328, 253338, 253358, 253360, 253372, 253379, 253386, 253392, 253394, 253405, 253406, 253417, 253428, 253431, 253434, 253439, 253440, 253463, 253466, 253472, 253489, 253492, 253498, 253509, 253511, 253516, 253522, 253533, 253536, 253537, 253549, 253552, 253562, 253565, 253566, 253569, 253575, 253577, 253589, 253596, 253599, 253604, 253610, 253614, 253617, 253618, 253620, 253621, 253626, 253629, 253630, 253632, 253644, 253647, 253648, 253649, 253652, 253658, 253665, 253667, 253671, 253672, 253675, 253686, 253687, 253695, 253707, 253719, 253726, 253734, 253737, 253742, 253745, 253759, 253768, 253778, 253784, 253787, 253788, 253789, 253791, 253792, 253804, 253809, 253818, 253838, 253847, 253851, 253857, 253874, 253878, 253884, 253929, 253933, 253942, 253943, 253945, 253957, 253974, 253977, 254007, 254035, 254076, 254085, 254104, 254114, 254122, 254124, 254130, 254131, 254140, 254148, 254150, 254157, 254166, 254181, 254182, 254185, 254208, 254217, 254224, 254248, 254249, 254258, 254274, 254275, 254279, 254294, 254304, 254316, 254328, 254334, 254375, 254409, 254410, 254417, 254423, 254432, 254436, 254437, 254439, 254462, 254471, 254489, 254498, 254501, 254504, 254507, 254510, 254519, 254520, 254526, 254532, 254575, 254586, 254589, 254601, 254605, 254606, 254611, 254666, 254677, 254682, 254683, 254694, 254697, 254750, 254764, 254770, 254802, 254806, 254827, 254829, 254863, 254864, 254932, 254969, 254986, 255054.  Model E110, serial numbers: 111337, 112160, 116438, 116482, 116485, 117042, 117139, 118578, 119741, 120982, 121094, 121712, 121788, 121926, 121949, 122366, 122400, 122408, 122441, 122484, 122544, 122655, 122668, 122712, 122724, 122790, 122900, 123394, 123524, 123869, 123947, 124820, 124993, 125532, 125601, 125781, 125834, 126201, 126222, 126267, 126281, 126317, 126539, 126712, 126741, 126806, 126807, 126833, 126981, 127006, 127014, 127020, 127044, 127047, 127109, 127120, 127140, 127179, 127210, 127217, 127251, 127373, 127394, 127404, 127408, 127428, 127481, 127514, 127720, 127854, 127886, 127903, 127967, 128025, 128033, 128085, 128091, 128139, 128151, 128274, 128326, 128403, 128469, 128572, 129050, 129056, 129168, 129191, 129293, 129346, 129358, 129435, 129477, 129531, 129540, 129637, 129709, 129754, 129767, 129790, 129797, 129804, 129857, 129867, 129906, 129977, 129990, 130000, 130022, 130041, 130106, 130107, 130120, 130144, 130162, 130164, 130185, 130206, 130271, 130305, 130415, 130447, 130470, 130471, 130577, 130716, 130851, 130980, 131059, 131064, 131135, 131167, 131188, 131226, 131242, 131294, 131358, 131365, 131367, 131425, 131427, 131439, 131466, 131469, 131470, 131481, 131482, 131487, 131493, 131506, 131507, 131512, 131524, 131525, 131540, 131565, 131600, 131604, 131608, 131622, 131626, 131636, 131651, 131653, 131661, 131662, 131674, 131676, 131693, 131694, 131708, 131709, 131716, 131717, 131718, 131723, 131733, 131737, 131764, 131765, 131766, 131779, 131799, 131802, 131824, 131830, 131845, 131853, 131857, 131863, 131864, 131878, 131881, 131893, 131907, 131922, 131925, 131926, 131958, 131965, 131972, 131999, 132016, 132039, 132046, 132050, 132055, 132062, 132070, 132073, 132074, 132079, 132091, 132099, 132102, 132119, 132128, 132131, 132132, 132145, 132147, 132177, 132184, 132236, 132252, 132280, 132387, 132393, 132407, 132422, 132534, 132551, 132577, 132616, 132623, 132636, 132699, 132704, 132734, 132755, 132776, 132869, 132870, 132872, 132873, 132889, 132910, 132917, 132944, 132974, 132990, 133035, 133047, 133053, 133112, 133131, 133188, 133198, 133225, 133291, 133295, 133338, 133351, 133388, 133419, 133422, 133466, 133508, 133551, 133591, 133608, 133632, 133634, 133652, 133695, 133713, 133717, 133746, 133766, 133781, 133821, 133833, 133843, 133855, 133863, 133894, 133896, 133906, 133913, 133933, 133936, 133953, 133955, 133956, 133969, 133976, 133999, 134013, 134040, 134044, 134049, 134056, 134060, 134062, 134064, 134088, 134093, 134094, 134115, 134129, 134138, 134159, 134235, 134237, 134277, 134281, 134306, 134312, 134320, 134329, 134339, 134351, 134353, 134355, 134359, 134360, 134365, 134367, 134369, 134374, 134375, 134382, 134385, 134401, 134404, 134417, 134429, 134435, 134441, 134458, 134471, 134480, 134481, 134489, 134511, 134517, 134519, 134536, 134539, 134545, 134559, 134565, 134577, 134581, 134587, 134592, 134604, 134608, 134618, 134631, 134634, 134646, 134652, 134667, 134685, 134694, 134710, 134711, 134715, 134716, 134718, 134720, 134725, 134743, 134749, 134776, 134783, 134797, 134823, 134827, 134829, 134842, 134861, 134867, 134883, 134906, 134910, 134939, 134948, 134952, 134954, 134978, 134987, 135004, 135018, 135023, 135045, 135059, 135060, 135067, 135069, 135073, 135079, 135098, 135110, 135123, 135130, 135140, 135144, 135194, 135226, 135230, 135258, 135261, 135287, 135297, 135299, 135304, 135326, 135327, 135329, 135332, 135333, 135341, 135350, 135355, 135363, 135377, 135385, 135389, 135406, 135408, 135415, 135422, 135426, 135428, 135431, 135434, 135453, 135455, 135466, 135472, 135473, 135475, 135480, 135489, 135499, 135504, 135513, 135514, 135571, 135581, 135591, 135604, 135659, 135712, 135718, 135826, 135868, 135938, 136008, 136042, 136076, 136284, 136323, 136369, 137744, 137765, 137776, 137780, 137787, 137803, 137818, 137847, 137850, 137852, 137868, 137869, 137870, 137872, 137903, 137907, 137924, 137928, 137953, 137957, 137975, 138009, 138025, 138035, 138053, 138063, 138082, 138084, 138090, 138091, 138115, 138132, 138155, 138163, 138168, 138193, 138199, 138209, 138212, 138231, 138244, 138263, 138266, 138327, 138330, 138355, 138360, 138361, 138369, 138383, 138388, 138389, 138405, 138412, 138413, 138416, 138448, 138460, 138462, 138468, 138472, 138479, 138480, 138504, 138517, 138518, 138545, 138546, 138547, 138564, 138581, 138584, 138588, 138596, 138598, 138605, 138628, 138630, 138646, 138669, 138692, 138697, 138698, 138709, 138720, 138727, 138736, 138739, 138744, 138764, 138771, 138776, 138780, 138816, 138819, 138834, 138839, 138841, 138846, 138849, 138856, 138858, 138877, 138900, 138918, 138935, 138940, 138941, 138942, 138955, 138962, 138974, 138977, 138978, 139018, 139028, 139031, 139039, 139042, 139044, 139046, 139050, 139053, 139060, 139067, 139085, 139086, 139098, 139101, 139109, 139113, 139128, 139129, 139130, 139182, 139207, 139219, 139223, 139237, 139263, 139300, 139315, 139337, 139345, 139351, 139361, 139372, 139373, 139387, 139394, 139396, 139403, 139408, 139412, 139413, 139418, 139421, 139423, 139430, 139435, 139447, 139448, 139456, 139458, 139459, 139460, 139461, 139467, 139468, 139472, 139494, 139503, 139507, 139511, 139529, 139546, 139547, 139563, 139569, 139575, 139579, 139590, 139598, 139599, 139612, 139613, 139622, 139636, 139640, 139651, 139652, 139668, 139671, 139683, 139685, 139689, 139715, 139746, 139748, 139760, 139768, 139773, 139793, 139802, 139817, 139824, 139840, 139842, 139846, 139852, 139854, 139855, 139863, 139871, 139878, 139887, 139888, 139894, 139896, 139906, 139910, 139911, 139917, 139918, 139924, 139925, 139926, 139928, 139929, 139931, 139934, 139936, 139942, 139949, 139952, 139953, 139959, 139963, 139964, 139971, 139973, 139980, 139984, 139985, 139987, 140001, 140005, 140007, 140010, 140011, 140016, 140019, 140029, 140030, 140044, 140046, 140053, 140056, 140071, 140075, 140102, 140121, 140125, 140127, 140135, 140137, 140150, 140157, 140180, 140182, 140184, 140186, 140199, 140202, 140204, 140215, 140217, 140222, 140224, 140227, 140234, 140241, 140251, 140256, 140269, 140271, 140299, 140302, 140310, 140311, 140312, 140322, 140326, 140338, 140340, 140346, 140365, 140383, 140389, 140404, 140435, 140525, 140535, 140574, 140637, 140648, 140650, 140651, 140656, 140672, 140674, 140682, 140696, 140717, 140720, 140721, 140722, 140730, 140738, 140769, 140773, 140782, 140795, 140800, 140814, 140831, 140833, 140847, 140869, 140875, 140891, 140899, 140913, 140944, 140950, 140984, 141016, 141035, 141144, 141145, 141195, 141257, 141260, 141270, 141322, 141438, 141470, 141492, 141511, 141594, 141646, 141753.

Cardiovascular Devices

3

Yes

nationwide within US only (OUS distribution not affected).

Boston Scientific TELIGEN, Implantable Cardiac Defibrillator, Models E102 and E110. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 66112-5798, USA. The product is indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. COGNIS devices also provide bi-ventricular pacing.

Model N118, serial numbers: 564225, 568144, 569074, 569104, 569150, 569690, 569737, 569866, 569996, 569998, 570003, 578083, 578441, 578668, 578673, 578746, 578748, 578758, 578761, 578800, 578810, 578822, 578834, 578845, 578855, 578893, 578918, 578921, 578924, 578944, 578945, 578953, 578956, 578975, 578978, 578984, 579024, 579031, 579043, 579055, 579070, 579085, 579100, 579105, 579123, 579200, 579228, 579448, 579502, 579519, 579587, 579595, 579605, 579624, 579707, 579773, 579776, 579780, 579789, 579793, 579794, 579795, 579798, 579800, 579803, 579809, 579810, 579811, 579813, 579817, 579818, 579819, 579844, 579857, 579862, 579866, 579868, 579879, 579880, 579894, 579897, 579900, 579906, 579914, 579916, 579920, 579927, 580007, 580315, 580337, 580379, 580391, 581909, 581922, 581960, 581966, 581974, 581999, 582012, 582025, 582028, 582052, 582068, 582069, 582094, 582099, 582101, 582105, 582131, 582137, 582152, 582159, 582200, 582225, 582278, 582279, 582280, 582313, 582317, 582329, 582330, 582347, 582365, 582402, 582405, 582407, 582412, 582447, 582457, 582471, 582495, 582508, 582551, 582564, 582589, 582590, 582727, 582787, 582820, 582823, 582827, 582830, 582863, 582882, 582887, 582918, 582945, 582958, 582961, 582966, 582993, 582997, 582998, 583006, 583020, 583021, 583034, 583038, 583039, 583052, 583058, 583060, 583076, 583077, 583079, 583093, 583094, 583117, 583140, 583141, 583148, 583185, 583217, 583233, 583245, 583250, 583251, 583259, 583262.  Model N119, serial numbers: 058537, 058899, 058989, 169937, 171259, 172468, 173571, 174731, 175333, 180258, 181817, 181944, 182893, 184121, 185550, 186643, 186723, 188751, 189460, 190554, 190724, 192369, 193725, 194834, 196314, 196319, 196944, 197243, 197340, 197530, 198559, 198563, 198646, 199247, 199557, 200322, 200333, 201344, 201447, 202619, 203198, 206554, 206562, 207971, 208920, 208977, 209055, 209225, 947264, 947354, 948235, 948250, 948409, 948531, 948542, 948939, 949460, 949510, 949529, 949824, 949894, 953082, 953134, 953436, 953524, 953544, 953551, 954004, 954017, 954157, 954178, 954305, 954312, 954317, 954339, 954363, 954364, 954403, 954422, 954672, 954678, 954686, 954700, 954944, 954946, 954967, 955012, 955013, 955026, 955627, 955632, 955635, 955670, 955677, 955682, 955683, 955707, 955709, 955754, 955766, 955952, 955961, 955962, 955987, 955990, 955992, 956007, 956035, 956041, 956047, 956053, 956347, 956358, 956426, 956477, 956765, 957266, 957301, 957304, 957316, 957369, 957422, 957425, 957437, 957474, 957476, 957487, 957521, 957608, 957878, 957969, 958152, 958298, 958529, 958535, 958555, 958563, 958583, 958616, 958683, 958775, 958837, 958838, 958898, 958901, 958902, 959046, 959070, 959078, 959098, 959101, 959169, 959183, 959188, 959200, 959225, 959279, 959327, 959341, 959363, 959367, 959391, 959395, 959398, 959401, 959827, 960273, 960275, 960278, 960282, 960290, 960291, 960454, 960484, 960489, 960495, 960498, 960500, 960503, 960527, 960545, 960552, 960563, 960571, 960575, 960582, 960584, 960586, 960687, 960701, 960710, 960712, 960717, 960736, 960747, 960882, 960903, 960906, 960932, 960972, 960975, 960976, 960979, 961036, 961041, 961046, 961047, 961049, 961091, 961092, 961093, 961101, 961102, 961108, 961163, 961175, 961182, 961184, 961189, 961190, 961202, 961204, 961257, 961261, 961266, 961273, 961274, 961282, 961286, 961291, 961387, 961389, 961398, 961399, 961407, 961412, 961416, 961427, 961445, 961451, 961457, 961462, 961467, 961470, 961474, 961483, 961486, 961689, 961690, 961738, 961742, 961746, 961751, 961752, 961798, 961800, 961855, 961860, 961861, 961869, 961872, 961886, 961897, 961901, 961907, 961917, 962032, 962359, 962381, 962428, 962465, 962797, 963255, 963268, 963280, 963290, 963828, 964028, 964037, 964043, 964047, 964100, 964117, 964128, 964160, 964252, 964265, 964271, 964659, 964733, 965297, 966005, 966140, 968984, 968988, 968996, 968998, 969006, 969007, 969044, 969049, 969062, 969109, 969117, 969174, 970703, 970710, 970747, 970755, 970766, 970799, 970813, 970816, 970822, 970827, 970849, 970855, 970860, 970873, 970876, 970885, 970888, 970891, 970892, 970898, 970971, 971013, 971016, 971041, 971047, 971054, 971443, 971469, 971491, 971494, 972130, 972146, 972160, 972166, 972418, 972423, 972516, 972529, 972536, 972539, 972543, 972597, 972600, 972601, 972602, 972607, 972614, 972642, 972882, 972883, 972884, 972916, 972920, 972922, 972925, 972927, 972932, 972947, 972963, 973325, 973333, 973340, 973345, 973348, 973452, 973454, 973462, 973467, 973479, 973496, 973513, 973590, 973591, 973709, 973728, 973736, 973738, 973749, 973750, 974239, 974245, 974252, 974256, 974260, 974269, 974285, 974288, 974290, 974297, 974307, 974379, 974398, 974423, 974432, 974527, 974560, 974564, 974584, 974590, 974598, 974636, 975007, 975021, 975039, 975051, 975059, 975061, 975160, 975164, 975200, 975476, 975490, 975492, 975599, 975607, 975683, 975730, 975813, 975830, 975836, 975901, 976453, 976454, 976455, 976457, 976462, 976492, 976493, 976499, 976503, 976507, 976510, 976515, 976524, 976540, 976542, 976580, 976582, 976843, 976853, 976863, 976869, 976871, 976904, 976924, 976926, 976932, 977014, 977030, 977034, 977050, 977122, 977126, 977132, 977150, 977152, 977157, 977163, 977176, 977178, 977179, 977190, 977191, 977192, 977725, 977727, 977732, 977746, 977752, 977754, 977771, 977778, 977782, 977784, 977805, 977809, 977824, 977826, 977827, 977850, 977907, 977908, 977932, 977933, 977936, 977939, 977940, 977943, 977944, 977945, 977946, 977954, 977958, 978020, 978028, 978396, 978402, 978410, 978419, 978420, 978428, 978434, 978437, 978445, 978446, 978448, 978454, 978458, 978462, 978465, 978471, 978472, 978474, 978486, 978492, 978506, 978553, 978570, 978578, 978580, 978586, 978600, 978601, 978616, 978623, 978628, 978689, 978694, 978695, 978696, 978708, 978712, 978716, 978718, 978964, 978966, 978967, 978970, 978977, 978978, 979023, 979024, 979025, 979029, 979034, 979035, 979047, 979048, 979050, 979101, 979107, 979401, 979409, 979418, 979524, 979529, 979533, 979603, 979611, 979619, 979697, 979709, 979739, 979744, 979748, 979749, 979751, 979756, 979757, 979766, 979771, 979775, 979777, 979778, 979780, 979804, 979805, 979807, 979810, 979815, 979839, 979857, 979865, 979868, 979873, 979881, 980113, 980115, 980116, 980117, 980123, 980126, 980129, 980559, 980577, 980675, 980702, 980868, 980872, 981344, 981423, 981424, 981491, 981837, 981840, 981906, 981972, 981983, 981988, 982610, 982863, 983662, 983999, 984030, 984044.

Cardiovascular Devices

3

Yes

nationwide within US only (OUS distribution not affected).

Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, Models N118 and N119. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 66112-5798, USA. The product is indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. COGNIS devices also provide bi-ventricular pacing.

Model E030, serial numbers: 504800, 505054, 505073, 506067, 506886, 506961, 507219, 507236, 507255, 507268, 507292, 507304, 507332, 507372, 507381, 507388, 507412, 507424, 507446, 507448, 507449, 507454, 507467, 507527, 507538, 507577, 507594, 507600, 507607, 507614, 507618, 507625, 507728, 507742, 507757, 507785, 507829, 507840, 507882, 507898, 507903, 507904, 507923, 507940, 507943, 507944, 507952, 507960, 507963, 507966, 507984, 508001, 508008, 508059, 508130.

Cardiovascular Devices

3

Yes

nationwide within US only (OUS distribution not affected).

Boston Scientific CONFIENT, model E030, Implantable Cardioverter Defibrillator (ICD). The CONFIENT Implantable Cardioverter Defibrillator (ICDs) are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation(VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-energy shocks using either a biphasic or monophasic waveform. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue, St. Paul, MN 55112-5798. USA.

Model H220, serial numbers: 511302, 512322, 513553, 513555, 513592, 513617, 513637, 513638, 513641, 513653, 513741, 513876, 513883, 513886, 513888, 513906, 513940, 513951, 513954, 513988, 514010, 514029, 514033, 514041, 514044, 514047, 514060, 514065, 514070, 514080, 514105, 514107, 514121, 514129.  Model H225, serial numbers: 562014, 562031, 562033, 562040, 562067, 562080, 562116, 562124, 562129, 562133.  Model H227, serial numbers: 511024, 561060, 561618, 562179, 562439, 562789, 563298, 563319, 563323, 563342, 563350, 563366, 563391, 563395, 563400, 563411, 563470, 563484, 563532, 563535, 563547, 563589, 563608, 563615, 563616, 563624, 563662, 563714, 563771, 563785, 563799, 563801, 563804, 563820, 563823, 563824, 563825, 563829, 563831, 563832, 563833, 563840, 563845, 563846, 563847, 563852, 563853, 563854, 563855, 563908, 563918, 563934, 563957, 563962, 563967, 563970, 563972, 563976.  Model H229, serial numbers: 560803, 560813, 560837, 560872, 560873, 560891, 560918, 560921, 560946, 560958, 560959, 560968, 560978, 560985, 561002, 561006, 561021, 561023, 561028, 561030, 561036, 561040, 561057, 561061, 561069, 561073, 561077, 561080, 561092, 561095, 561155, 561158, 561160.

Cardiovascular Devices

3

Yes

nationwide within US only (OUS distribution not affected).

Boston Scientific LIVIAN Cardiac Resynchronization Therapy Defibrillator (CRT-D), models H220, H225, H227, H229. The LIVIAN family of cardiac resynchronization therapy defibrillators (CRT-Ds), provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure(HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue, St. Paul, MN 55112-5798 USA.

The device serial numbers are only provided for devices subject to the retrieval. For model number with no serial numbers there were no non-implanted devices with domestic customers. Once the required BSC submissions and FDA reviews are completed, the BSCs distribution and implant restrictions will no longer apply.  Model H175, no serial numbers will be retrieved. Model H170, serial numbers: 367529, 367531, 367582, 367593. Model H177, serial number 286645. Model H179, serial number 115199.

Cardiovascular Devices

3

Yes

nationwide within US only (OUS distribution not affected).

CONTAK RENEWAL 3 (Models H170), Guidant CONTAK RENEWAL 3 HE (Models H177, H179). Cardiac Resynchronization Therapy Defibrillator (CRT-D). These CRT-Ds provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. Cardioversion/defibrillation therapies include a range of low- and high-energy shocks using either a biphasic or monophasic waveform. Sterile EO. Boston Scientific Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.

The device serial numbers are only provided for devices subject to the retrieval. For model number with no serial numbers there were no non-implanted devices with domestic customers. Once the required BSC submissions and FDA reviews are completed, the BSCs distribution and implant restrictions will no longer apply.  Model 1850, 1852, 1855 and 1856, no serial numbers will be retrieved. Model 1851, serial number: 301173  Model 1853, serial number: 405161  Model 1857, serial numbers: 701901, 705521, 705555, 705564, 705568, 705575, 705624, 705721, 705759, 705774.   Model 1858, serial numbers: 801463, 801487, 801489, 801505, 801511, 801512, 801517,   Model 1860, serial number 131043  Model 1861, serial numbers 201166, 230949

Cardiovascular Devices

3

Yes

nationwide within US only (OUS distribution not affected).

VENTAK PRIZM Automatic Implantable Cardioverter Defibrillator (AICD). DR, model 1851, DR HE, model 1853 and 1858, PRIZM VR HE, model 1857, PRIZM 2 VR model 1860 and PRIZM 2 DR model 1861. The ICDs are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-energy shocks using either a biphasic or monophasic waveform. Bradycardia pacing, including adaptive-rate features is available to detect and treat bradyarrhythmias and to support the cardiac rhythm after defibrillation therapy. The devices denoted with DR offer dual-chamber bradycardia features (atrial and/or ventricular pacing and sensing), and the devices denoted with VR offer single-chamber bradycardia features (ventricular pacing and sensing). Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA

UPN M002004810260; Lot 11423751; Exp 12/2010

Cardiovascular Devices

2

Yes

Worldwide distribution: USA including states of TX, NJ, SC, MO, ID, TN, FL, CA, PA and Canada and Germany.

EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm; L: 50 cm straight. || Sterile || Intended use: The Standard Wall EXXCEL and EXXCEL Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Wall Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries.

UPN M002004948580; Lot 11407455, Exp 12/2010.

Cardiovascular Devices

2

Yes

Worldwide distribution: USA including states of TX, NJ, SC, MO, ID, TN, FL, CA, PA and Canada and Germany.

EXXCEL Soft Thin Wall EPTFE Vascular Graft; D:8 mm; L: 50 cm straight. || Sterile || Intended use: The Standard Wall EXXCEL and EXXCEL Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Wall Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries.

Lot # 7964590

Cardiovascular Devices

2

Yes

Worldwide Distribution - USA (nationwide) and the countries of the UK, and France.

Axium Detachable Coil System QC-7-30-Helix || The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae.

Model D274TRK, serial numbers: PZV200009H thru PZV200026H, PZV200028H thru PZV200043H, PZV200045H thru PZV200077H, PZV200079H thru PZV200113H, PZV200115H thru PZV200281H, PZV200283H, PZV200285H thru PZV200318H, PZV200320H thru PZV200332H. PZV200334H thru PZV200354H, PZV200356H thru PZV200414H, PZV200416H thru PZV200548H, PZV200550H thru PZV200555H, PZV200557H thru PZV200645H, PZV200647H, PZV200648H thru PZV200783H, PZV200785H thru PZV200950H, PZV200952H thru PZV201125H, PZV201128H thru PZV201184H, PZV201186H thru PZV201232H, PZV201234H thru PZV201423H, PZV201425H thru PZV201501H, PZV201503H thru PZV201622H, PZV201624H thru PZV201834H, PZV201836H thru PZV201960H, PZV201963H thru PZV202137H, PZV202139H thru PZV202368H, PZV202370H thru PZV202458H, PZV202460H thru PZV202629H, PZV202631H thru PZV202692H, PZV202694H thru PZV202885H, PZV202887H thru PZV203066H, PZV203068H thru PZV203152H, PZV203154H thru PZV203196H, PZV203198H thru PZV203293H, PZV203296H thru PZV203300H, PZV203302H thru PZV203372H, PZV203374H thru PZV203527H, PZV203529H thru PZV203637H, PZV203639H thru PZV203654H, PZV203656H thru PZV203723H, PZV203725H thru PZV203748H, PZV203750H thru PZV203911H, PZV203913H, PZV203914H, PZV203915H, PZV203917H thru PZV204157H, PZV204159H thru PZV204194H, PZV204196H thru PZV204408H, PZV204410H thru PZV204763H, PZV204765H thru PZV204869H, PZV204872H thru PZV205216H, PZV205218H thru PZV205229H, PZV205231H thru PZV205332H. PZV205335H thru PZV205368H, PZV205370H thru PZV205420H, PZV205422H thru PZV205444H, PZV205446H thru PZV205490H, PZV205492H thru PZV205542H, PZV205544H thru PZV205604H, PZV205606H thru PZV205691H, PZV205693H thru PZV205696H, PZV205698H thru PZV205784H, PZV205786H thru PZV205795H, PZV205797H thru PZV205848H, PZV205850H thru PZV205953H, PZV205955H thru PZV205966H, PZV205968H thru PZV206175H, PZV206177H thru PZV206276H, PZV206279H, PZV206280H, PZV206282H thru PZV206458H, PZV206460H thru PZV206541H, PZV206544H thru PZV206575H, PZV206578H, PZV206580H thru PZV206627H, PZV206629H thru PZV206636H, PZV206638H thru PZV206689H, PZV206692H thru PZV206727H, PZV206729H thru PZV206759H, PZV206761H thru PZV206827H, PZV206829H thru PZV206946H, PZV206948H thru PZV207176H, PZV207178H thru PZV207271H, PZV207273H, PZV207274H, PZV207276H thru PZV207278H, PZV207280H thru PZV207292H, PZV207294H thru PZV207598H, PZV207600H thru PZV207625H, PZV207627H thru PZV207885H, PZV207887H thru PZV207934H, PZV207936H thru PZV208044H, PZV208046H thru PZV208091H, PZV208093H thru PZV208101H, PZV208103H thru PZV208109H, PZV208111H thru PZV208184H, PZV208186H thru PZV208278H, PZV208280H thru PZV208309H, PZV208311H thru PZV208334H, PZV208336H thru PZV208487H, PZV208489H thru PZV208591H, PZV208593H thru PZV208669H, PZV208671H thru PZV208725H, PZV208727H thru PZV208740H, PZV208742H thru PZV208871H, PZV208873H thru PZV208934H, PZV208936H thru PZV209034H, PZV209036H thru PZV209072H, PZV209074H thru PZV209113H, PZV209115H thru PZV209248H, PZV209250H thru PZV209337H, PZV209339H thru PZV209650H, PZV209652H thru PZV209682H, PZV209684H thru PZV209818H, PZV209820H, PZV209821H, PZV209823H thru PZV209940H, PZV209942H thru PZV209967H, PZV209969H thru PZV210050H, PZV210052H thru PZV210334H, PZV210337H thru PZV210614H, PZV210616H thru PZV210814H, PZV210816H thru PZV210998H, PZV211000H thru PZV211045H, PZV211047H thru PZV211252H, PZV211254H thru PZV211358H, PZV211360H thru PZV211390H, PZV211392H thru PZV211467H, PZV211469H thru PZV211635H, PZV211637H thru PZV211834H, PZV211836H thru PZV211886H, PZV211888H thru PZV212032H, PZV212034H thru PZV212071H, PZV212073H thru PZV212267H, PZV212269H thru PZV212343H, PZV212344H thru PZV212411H, PZV212413H thru PZV212626H, PZV212628H thru PZV212817H, PZV212819H thru PZV212939H, PZV212941H thru PZV213225H, PZV213227H thru PZV213322H, PZV213324H thru PZV213356H, PZV213358H thru PZV213464H, PZV213466H thru PZV213485H, PZV213487H, PZV213493H thru PZV213544H, PZV213546H thru PZV213734H, PZV213736H thru PZV213779H, PZV213781H thru PZV213934H, PZV213936H thru PZV214168H, PZV214171H thru PZV214191H, PZV214193H thru PZV214276H, PZV214278H thru PZV214390H, PZV214392H thru PZV214400H, PZV214402H thru PZV214419H, PZV214421H thru PZV214660H, PZV214662H thru PZV214691H, PZV214693H thru PZV214754H, PZV214756H thru PZV214781H, PZV214783H thru PZV214862H, PZV214865H thru PZV214893H, PZV214895H thru PZV214918H, PZV214921H, PZV214923H thru PZV214966H, PZV214968H thru PZV214981H, PZV214983H, PZV214984H, PZV214986H thru PZV214994H, PZV214996H thru PZV215033H, PZV215035H thru PZV215235H, PZV215237H thru PZV215253H, PZV215255H thru PZV215262H, PZV215264H thru PZV215353H, PZV215355H thru PZV215381H, PZV215383H thru PZV215492H, PZV215494H thru PZV215663H, PZV215665H thru PZV215696H, PZV215698H, PZV215702H, PZV215704H, PZV215705H, PZV215707H, PZV215711H thru PZV215714H, PZV215716H, PZV215719H thru PZV215725H, PZV215754H, PZV215755H, PZV215757H, PZV215759H, PZV215760H, PZV215761H, PZV215763H, PZV215765H, PZV215782H, PZV215784H, PZV215787H, PZV215789H, PZV215790H, PZV215791H, PZV215792H, PZV215793H, PZV215813H, PZV215816H, PZV215818H, PZV215820H, PZV215823H, PZV215845H, PZV215864H, PZV215929H, PZV215930H, PZV215932H, PZV215934H, PZV215936H, PZV215957H, PZV215958H, PZV216041H.    Model D294TRK, serial numbers: PZU600001S thru PZU600035S, PZU600037S thru PZU600110S , PZU600112S thru PZU600213S , PZU600215S thru PZU600234S, PZU600236S thru PZU600417S, PZU600419S thru PZU600549S, PZU600551S thru PZU600692S, PZU600694S, PZU600695S, PZU600697S thru PZU600739S, PZU600741S thru PZU600805S, PZU600807S thru PZU600827S, PZU600829S thru PZU600840S, PZU600842S thru PZU601052S, PZU601054S thru PZU601289S, PZU601291S thru PZU601507S, PZU601509S thru PZU601720S, PZU601722S thru PZU601786S, PZU601788S thru PZU602260S, PZU602262S thru PZU602512S, PZU602514S thru PZU602527S, PZU602529S thru PZU602579S, PZU602581S thru PZU602799S, PZU602801S thru PZU602926S, PZU602928S thru PZU603200S, PZU603202S thru PZU603212S, PZU603215S thru PZU603264S.

Cardiovascular Devices

3

Yes

Worldwide Distribution - USA, Puerto Rico, Virgin Islands, and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saint Lucia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City, Venezuela, and Viet Nam.

Medtronic Concerto II CRT-D, model D274TRK and Model D294TRK not available in the US. Digital implantable cardioverter defibrillator with cardiac resynchronization therapy (DDE-DDR). Sterilized using ethylene oxide. Medtronic, Inc., Minneapolis, MN 55432 USA. Manufactured in: Juncos, Puerto Rico, USA. || The Dual chamber implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT-D) is a multiprogrammable cardiac device that monitors and regulates the patient's heart rate by providing single or dual chamber rate-responsive bradycardia pacing, sequential biventricular pacing, ventricular tachyarrhythmia therapies, and atrial tachyarrhythmia therapies. The device automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device also automatically detects atrial tachyarrhythmias (AT/AF) and provides treatment with cardioversion and antitachycardia pacing therapies. Simultaneous or sequential biventricular pacing is used to provide patients with cardiac resynchronization therapy. The device responds to bradyarrhythmias by providing bradycardia pacing therapies.

Model D224TRK, serial numbers: PUD200144H, PUD200145H, PUD200147H thru PUD200166H, PUD200168H thru PUD200243H, PUD200245H thru PUD200272H, PUD200274H, PUD200275H, PUD200277H thru PUD200399H, PUD200401H thru PUD200409H, PUD200411H thru PUD200526H, PUD200528H thru PUD200651H, PUD200653H, PUD200655H thru PUD200755H, PUD200757H thru PUD201041H, PUD201043H thru PUD201150H, PUD201152H thru PUD201306H, PUD201308H thru PUD201311H, PUD201313H thru PUD201345H, PUD201347H thru PUD201374H, PUD201376H thru PUD201381H, PUD201383H thru PUD201387H, PUD201389H thru PUD201431H, PUD201433H thru PUD201435H, PUD201437H. PUD201439H, PUD201441H, PUD201444H thru PUD201513H, PUD201515H thru PUD201573H, PUD201575H thru PUD201596H, PUD201598H thru PUD201691H, PUD201694H thru PUD201734H, PUD201736H thru PUD201757H, PUD201759H thru PUD201764H, PUD201766H thru PUD201966H, PUD201968H thru PUD202049H, PUD202051H thru PUD202092H, PUD202094H thru PUD202120H, PUD202122H thru PUD202170H, PUD202172H thru PUD202192H, PUD202194H, PUD202195H, PUD202197H thru PUD202231H, PUD202233H thru PUD202252H, PUD202254H thru PUD202354H, PUD202356H thru PUD202366H, PUD202368H thru PUD202488H, PUD202490H thru PUD202505H, PUD202507H thru PUD202528H, PUD202530H thru PUD202579H, PUD202581H thru PUD202680H, PUD202682H thru PUD202698H, PUD202700H thru PUD202864H, PUD202866H thru PUD202926H, PUD202928H thru PUD203009H, PUD203011H thru PUD203086H, PUD203088H thru PUD203109H, PUD203111H thru PUD203145H, PUD203147H thru PUD203303H, PUD203305H thru PUD203320H, PUD203322H thru PUD203401H, PUD203403H thru PUD203660H, PUD203662H thru PUD203772H, PUD203774H thru PUD203814H, PUD203816H thru PUD203956H, PUD203958H thru PUD203976H, PUD203978H thru PUD204080H, PUD204082H thru PUD204158H, PUD204160H thru PUD204224H, PUD204226H thru PUD204282H, PUD204284H thru PUD204316H, PUD204318H thru PUD204322H, PUD204324H thru PUD204753H, PUD204755H thru PUD204769H, PUD204771H thru PUD204812H, PUD204814H, PUD204816H thru PUD204820H, PUD204822H thru PUD204979H, PUD204981H, PUD204982H, PUD204984H  thru PUD205156H, PUD205158H thru PUD205180H, PUD205182H thru PUD205213H, PUD205215H thru PUD205235H, PUD205237H thru PUD205241H, PUD205243H, PUD205251H, PUD205252H, PUD205254H thru PUD205457H, PUD205459H thru PUD205476H, PUD205478H thru PUD205537H, PUD205539H thru PUD205556H, PUD205558H thru PUD205561H, PUD205563H thru PUD205607H, PUD205609H thru PUD205736H, PUD205738H thru PUD206015H, PUD206017H thru PUD206105H, PUD206107H thru PUD206233H, PUD206235H thru PUD206242H, PUD206245H thru PUD206269H, PUD206271H thru PUD206313H, PUD206315H thru PUD206408H, PUD206410H thru PUD206436H, PUD206438H thru PUD206540H, PUD206542H thru PUD206649H, PUD206651H thru PUD206720H, PUD206722H thru PUD206903H, PUD206905H thru PUD206957H, PUD206959H thru PUD206985H, PUD206987H thru PUD207046H, PUD207048H thru PUD207076H, PUD207078H thru PUD207083H, PUD207085H thru PUD207096H, PUD207097H thru PUD207099H, PUD207101H thru PUD207175H, PUD207177H thru PUD207282H, PUD207285H thru PUD207366H, PUD207368H thru PUD207420H, PUD207422H thru PUD207562H, PUD207564H thru PUD207697H, PUD207699H thru PUD207731H, PUD207733H thru PUD207788H, PUD207790H thru PUD207934H, PUD207936H thru PUD207963H, PUD207965H thru PUD208121H, PUD208123H thru PUD208251H, PUD208253H thru PUD208306H, PUD208308H thru PUD208339H, PUD208341H thru PUD208475H, PUD208477H thru PUD208486H, PUD208488H thru PUD208530H, PUD208532H thru PUD208962H, PUD208964H thru PUD209021H, PUD209023H, PUD209031H, PUD209032H, PUD209034H thru PUD209080H, PUD209082H thru PUD209106H, PUD209108H thru PUD209113H, PUD209115H thru PUD209133H, PUD209135H thru PUD209205H, PUD209207H thru PUD209276H, PUD209278H thru PUD209328H, PUD209330H thru PUD209334H, PUD209336H thru PUD209399H, PUD209401H thru PUD209580H, PUD209582H thru PUD209613H, PUD209615H thru PUD209618H, PUD209620H thru PUD209720H, PUD209722H, PUD209724H thru PUD209747H, PUD209749H thru PUD210001H, PUD210003H thru PUD210010H, PUD210012H thru PUD210047H, PUD210049H thru PUD210111H, PUD210113H thru PUD210232H, PUD210234H thru PUD210346H, PUD210348H thru PUD210364H, PUD210366H thru PUD210551H, PUD210553H thru PUD210617H, PUD210619H thru PUD210770H, PUD210773H thru PUD210844H, PUD210846H thru PUD211033H, PUD211035H thru PUD211164H, PUD211166H thru PUD211190H, PUD211192H thru PUD211376H, PUD211378H thru PUD211396H, PUD211398H, PUD211399H, PUD211400H, PUD211401H, PUD211403H thru PUD211415H, PUD211417H thru PUD211453H, PUD211455H thru PUD211506H, PUD211508H thru PUD211591H, PUD211593H thru PUD211612H, PUD211614H, PUD211615H, PUD211617H thru PUD211685H, PUD211688H thru PUD211806H, PUD211808H thru PUD211840H, PUD211842H thru PUD211966H, PUD211968H thru PUD211978H, PUD211980H thru PUD212006H, PUD212008H thru PUD212014H, PUD212016H thru PUD212143H, PUD212145H thru PUD212739H, PUD212741H thru PUD212842H, PUD212844H thru PUD212966H, PUD212968H thru PUD213176H, PUD213178H thru PUD213415H, PUD213418H thru PUD213424H, PUD213426H thru PUD213444H, PUD213447H thru PUD213504H, PUD213506H thru PUD213635H, PUD213637H thru PUD213659H, PUD213661H thru PUD213682H, PUD213684H thru PUD213695H, PUD213698H thru PUD213743H, PUD213745H, PUD213747H thru PUD213816H, PUD213818H thru PUD213866H, PUD213871H thru PUD213949H, PUD213951H thru PUD214025H, PUD214027H thru PUD214051H, PUD214053H thru PUD214104H, PUD214106H thru PUD214163H, PUD214165H thru PUD214226H, PUD214229H PUD214230H, PUD214231H, PUD214232H, PUD214233H, PUD214235H, thru PUD214241H, PUD214243H thru PUD214344H, PUD214346H thru PUD214360H, PUD214362H thru PUD214437H, PUD214439H thru PUD214445H, PUD214447H thru PUD214477H, PUD214479H thru PUD214487H, PUD214489H thru PUD214649H, PUD214651H thru PUD214710H, PUD214712H thru PUD214741H, PUD214743H thru PUD215418H, PUD215420H thru PUD215719H, PUD215721H thru PUD215834H, PUD215836H thru PUD215885H, PUD215887H thru PUD215910H, PUD215912H thru PUD216001H, PUD216003H thru PUD216041H, PUD216043H thru PUD216086H, PUD216088H thru PUD216262H, PUD216264H thru PUD216294H, PUD216297H thru PUD216347H, PUD216353H thru PUD216372H, PUD216374H thru PUD216385H, PUD216387H thru PUD216400H, PUD216402H thru PUD216465H, PUD216467H thru PUD216968H, PUD216970H thru PUD217025H, PUD217027H thru PUD217049H, PUD217051H thru PUD217070H, PUD217072H thru PUD217138H, PUD217140H thru PUD217164H, PUD217166H thru PUD217254H, PUD217256H thru PUD217261H, PUD217263H thru PUD217317H, PUD217319H thru PUD217458H, PUD217460H thru PUD217464H, PUD217466H thru PUD217487H, PUD217489H thru PUD217494H, PUD217496H thru PUD217588H, PUD217590H thru PUD217638H, PUD217640H thru PUD217716H, PUD217718H thru PUD217962H, PUD217964H thru PUD218058H, PUD218060H thru PUD218108H, PUD218110H thru PUD218114H, PUD218116H thru PUD218165H, PUD218167H, PUD218169H thru PUD218221H, PUD218223H thru PUD218231H, PUD218233H thru PUD218256H, PUD218258H thru PUD218555H, PUD218557H thru PUD218615H, PUD218617H thru PUD218710H, PUD218712H thru PUD218825H, PUD218827H thru PUD218847H, PUD218849H thru PUD218899H, PUD218901H, PUD218902H, PUD218904H thru PUD219133H, PUD219135H thru PUD219145H, PUD219147H thru PUD219518H, PUD219520H thru PUD219627H, PUD219629H thru PUD219732H, PUD219734H, PUD219735H, PUD219736H, PUD219737H, PUD219738H, PUD219740H thru PUD219759H, PUD219761H thru PUD219856H, PUD219858H thru PUD220123H, PUD220125H thru PUD220150H, PUD220152H thru PUD220161H, PUD220163H thru PUD220263H, PUD220265H thru PUD220341H, PUD220343H thru PUD220484H, PUD220486H thru PUD220506H, PUD220508H thru PUD220635H, PUD220637H, PUD220638H thru PUD220727H, PUD220729H thru PUD220826H, PUD220828H thru PUD221320H, PUD221322H thru PUD221340H, PUD221343H PUD221344H, PUD221345H, PUD221346H, PUD221348H thru PUD221416H, PUD221418H thru PUD221570H, PUD221572H thru PUD221822H, PUD221824H thru PUD222146H, PUD222148H thru PUD222235H, PUD222237H thru PUD222322H, PUD222324H thru PUD222387H, PUD222389H thru PUD222453H, PUD222455H thru PUD222578H, PUD222580H thru PUD222631H, PUD222633H thru PUD222779H, PUD222781H thru PUD222795H, PUD222796H thru PUD222813H, PUD222815H thru PUD222886H, PUD222888H thru PUD223026H, PUD223028H thru PUD223106H, PUD223108H thru PUD223191H, PUD223193H thru PUD223212H, PUD223215H, PUD223217H thru PUD223578H, PUD223580H thru PUD223599H, PUD223601H, PUD223602H, PUD223604H, PUD223605H, PUD223607H thru PUD223631H, PUD223633H thru PUD223704H, PUD223706H thru PUD223877H, PUD223879H thru PUD223909H, PUD223911H thru PUD223917H, PUD223919H thru PUD223928H, PUD223930H thru PUD223959H, PUD223961H, PUD223962H, PUD223964H thru PUD223990H, PUD223992H thru PUD224000H, PUD224002H thru PUD224019H, PUD224023H PUD224029H, PUD224031H, PUD224036H, PUD224038H, PUD224040H, PUD224041H, PUD224046H thru PUD224053H, PUD224055H thru PUD224123H, PUD224125H thru PUD224210H, PUD224213H thru PUD224223H, PUD224225H thru PUD224241H, PUD224243H thru PUD224251H, PUD224253H thru PUD224283H, PUD224285H thru PUD224407H, PUD224409H thru PUD224498H, PUD224500H thru PUD224520H, PUD224522H thru PUD224841H, PUD224843H thru PUD224864H, PUD224866H thru PUD225057H, PUD225059H thru PUD225084H, PUD225086H, PUD225088H thru PUD225101H, PUD225103H thru PUD225107H, PUD225109H, PUD225111H thru PUD225263H, PUD225265H thru PUD225352H, PUD225354H thru PUD225417H, PUD225419H thru PUD225520H, PUD225522H thru PUD225542H, PUD225544H thru PUD225785H, PUD225787H thru PUD226007H, PUD226009H thru PUD226041H, PUD226043H thru PUD226121H, PUD226123H thru PUD226148H, PUD226150H thru PUD226218H, PUD226220H thru PUD226331H, PUD226333H thru PUD226425H, PUD226427H thru PUD226471H, PUD226473H thru PUD226607H, PUD226609H, PUD226610H, PUD226611H, PUD226613H thru PUD226626H, PUD226628H, PUD226629H, PUD226630H, PUD226631H, PUD226633H thru PUD226656H, PUD226658H thru PUD226731H, PUD226733H thru PUD226738H, PUD226740H thru PUD226778H, PUD226780H thru PUD226884H, PUD226886H thru PUD227063H, PUD227065H thru PUD227097H, PUD227099H thru PUD227104H, PUD227106H thru PUD227143H, PUD227145H thru PUD227220H, PUD227222H thru PUD227299H, PUD227301H thru PUD227387H, PUD227389H, PUD227391H thru PUD227549H, PUD227551H thru PUD227604H, PUD227606H thru PUD227655H, PUD227657H thru PUD227913H, PUD227915H thru PUD228276H, PUD228278H thru PUD228343H, PUD228345H thru PUD228402H, PUD228404H thru PUD228419H, PUD228421H thru PUD228515H, PUD228517H thru PUD228602H, PUD228604H thru PUD228631H, PUD228637H thru PUD228909H, PUD228911H thru PUD228936H, PUD228938H thru PUD228967H, PUD228969H thru PUD229156H, PUD229158H thru PUD229245H, PUD229247H thru PUD229363H, PUD229365H thru PUD229532H, PUD229534H thru PUD229541H, PUD229543H thru PUD229641H, PUD229643H thru PUD229669H, PUD229671H thru PUD229677H, PUD229679H thru PUD229698H, PUD229700H thru PUD229716H, PUD229718H thru PUD229861H, PUD229863H thru PUD229874H, PUD229876H thru PUD230053H, PUD230055H thru PUD230073H, PUD230075H, PUD230076H, PUD230077H, PUD230079H thru PUD230170H, PUD230172H thru PUD230201H, PUD230203H thru PUD230309H, PUD230311H thru PUD230578H, PUD230580H thru PUD230651H, PUD230653H thru PUD230704H, PUD230706H thru PUD230951H, PUD230953H thru PUD230959H, PUD230961H thru PUD231036H, PUD231038H thru PUD231227H, PUD231229H, PUD231230H, PUD231231H, PUD231233H thru PUD231339H, PUD231341H thru PUD231505H, PUD231507H thru PUD231853H, PUD231855H thru PUD232009H, PUD232011H thru PUD232020H, PUD232022H thru PUD232073H, PUD232075H thru PUD232113H, PUD232115H thru PUD232176H, PUD232178H, PUD232179H, PUD232180H, PUD232182H thru PUD232199H, PUD232201H thru PUD232319H, PUD232321H thru PUD232433H, PUD232435H thru PUD232442H, PUD232444H, PUD232445H, PUD232447H thru PUD232483H, PUD232485H thru PUD232593H, PUD232595H thru PUD233441H, PUD233443H thru PUD233614H, PUD233616 thru PUD233640H, PUD233642H thru PUD233864H, PUD233866H thru PUD233880H, PUD233882H, PUD233883H, PUD233884H, PUD233885H, PUD233886H, PUD233887H, PUD233889H thru PUD233912H, PUD233914H thru PUD234085H, PUD234087H thru PUD234390H, PUD234392H thru PUD234473H. PUD234476H thru PUD234495H, PUD234497H thru PUD234647H, PUD234649H thru PUD234664H. PUD234666H thru PUD234724H, PUD234726H thru PUD234862H, PUD234864H thru PUD235017H, PUD235019H thru PUD235224H, PUD235226H thru PUD235253H, PUD235255H thru PUD235277H, PUD235279H thru PUD235353H, PUD235355H thru PUD235397H, PUD235399H thru PUD235448H, PUD235450H thru PUD235644H, PUD235646H, PUD235647H, PUD235648H, PUD235649H, PUD235651H thru PUD235743H, PUD235745H thru PUD235775H, PUD235777H thru PUD235795H, PUD235797H, PUD235798H, PUD235799H, PUD235800H, PUD235801H, PUD235805H thru PUD235871H, PUD235877H,, PUD235882H thru PUD235930H, PUD235933H thru PUD235984H, PUD236092H, PUD236094H thru PUD236119H, PUD236121H thru PUD236152H, PUD236154H thru PUD236283H, PUD236285H thru PUD236508H, PUD236510H, PUD236511H, PUD236512H, PUD236518H thru PUD236556H, PUD236558H thru PUD236563H, PUD236565H thru PUD236584H, PUD236794H, PUD236797H, PUD236800H, PUD236802H, PUD236805H, PUD600062S, PUD600063S, PUD600081S, PUD600082S, PUD600083S, PUD600084S, PUD600086S, PUD600087S, PUD600089S, PUD600090S, PUD600091S, PUD600094S thru PUD600152S, PUD600154S thru PUD600185S, PUD600187S thru PUD600193S, PUD600195S thru PUD600268S, PUD600270S thru PUD600658S, PUD600660S thru PUD600793S, PUD600794S.

Cardiovascular Devices

3

Yes

Worldwide Distribution - USA, Puerto Rico, Virgin Islands, and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saint Lucia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City, Venezuela, and Viet Nam.

Medtronic Consulta CRT-D, model D224TRK and Model D234TRK not available in the US. Digital implantable cardioverter defibrillator with cardiac resynchronization therapy (DDE-DDDR). Sterilized using ethylene oxide. Medtronic, Inc., Minneapolis, MN 55432 USA. Manufactured in: Juncos, Puerto Rico, USA. || The Dual chamber implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT-D) is a multiprogrammable cardiac device that monitors and regulates the patient's heart rate by providing single or dual chamber rate-responsive bradycardia pacing, sequential biventricular pacing, ventricular tachyarrhythmia therapies, and atrial tachyarrhythmia therapies. The device automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device also automatically detects atrial tachyarrhythmias (AT/AF) and provides treatment with cardioversion and antitachycardia pacing therapies. Simultaneous or sequential biventricular pacing is used to provide patients with cardiac resynchronization therapy. The device responds to bradyarrhythmias by providing bradycardia pacing therapies.

xxx

Cardiovascular Devices

2

Yes

Nationwide Distribution.

Hemashield Gold Woven Double Velour Vascular Branch Graft