Lot # 9922452

Cardiovascular Devices

3

Yes

International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.

ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. || Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.

Lot # 9922795

Cardiovascular Devices

3

Yes

International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.

ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. || Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.

All lot/serial numbers are affected for all 4 Model numbers:  " Model 7425  " Model 3058  " Model 3023  " Model 3116

Neurological Devices

3

Yes

Worldwide Distributon- USA( nationwide including DC and PR) and Internationally to Mexico and Canada

The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, Peripheral Nervous System, or muscles when connected to an extension and/or lead. || The Medtronic InterStim II Neurostimulator, Model 3058, and Medtronic InterStim Neurostimulator, Model 3023, are parts of neurostimulation systems for InterStim Therapy. The neurostimulators are multiprogrammable devices that accommodates a lead through which a stimulation program is delivered. || The Medtronic Enterra Neurostimulator, Model 3116, is part of an Enterra Therapy system for gastric electrical stimulation (GES). The neurostimulator is a multiprogrammable device that accommodates a lead through which a stimulation program is delivered.

Product Codes- US product: Model No.: 1400, 1401US; International product: Model No.: 1400, 1401XX ('XX' represents country designation) Serial No.: CON000001 through CON005472

Cardiovascular Devices

3

Yes

Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NY, OH, OR, PA, TX, UT, VA, WA and District of Columbia and countries of: Canada, Poland, Australia, Austria, Italy, DE, New Zealand, South Africa, France, Switzerland, Germany, Brazil, UK, Belgium, Netherlands, Israel, Malaysia, Turkey, Greece, Japan, Singapore, Poland, Lithuania, Sweden, Norway, Finland, and India.

HeartWare Ventricular Assist System (HeartWare Controller) || Product Usage: || For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare System is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.

0007254814 0007266413 0007332504 0007332506 0007332508 0007332510 0007343321 0007343324 0007343327 0007350825 0007350837 0007354113 0007354245 0007366949 0007369883 0007393098 0007393101 0007408862 0007408865 0007408867 0007408869 0007428258 0007428260 0007428263 0007435169 0007439358 0007439360 0007439362 0007456292 0007456298 0007462901 0007462903 0007462905 0007476215 0007476217 0007476219 0007482219 0007482222 0007482226 0007486826 0007492356 0007495691 0007495694 0007495696 0007508883 0007508885 0007508891 0007515698 0007515700 0007515703 0007522595 0007522598 0007522600 0007522603 0007530963 0007530973 0007537892 0007537894 0007569474 0007569477 0007569482 0007573778 0007573785 0007573788 0007573791 0007579940 0007579944 0007579948 0007579951 0007592664 0007592666 0007592669 0007592672 0007598984

Cardiovascular Devices

3

Yes

Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Kuwait, Latvia, Lithuania, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates and United Kingdom.

EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. || Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system.

Cardiovascular Devices

3

Yes

Worldwide Distribution - USA (nationwide) including Puerto Rico and to Algeria, Argentina, Armenia, Australia, Austria, Bangladesh, Belarus, Belgium, Bermuda, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, French Polynesia, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary , India, Indonesia, Iran, Ireland, Israel, Italy, Japan Jordan, Kazakhstan, Kenya, Kuwait, Korea, Latvia, Luxembourg, Lebanon, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius , Mexico, Morocco, Netherlands, New Zealand, Norway,Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Trinidad, Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela and Vietnam.

Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.

RANGES OF LOT NUMBERS (all lot numbers within each range are affected) Lot # starting with P3C through P5B0289X  P5C0196X through P5C0197X  P5C0304X through P5C0307X  P5C0796X through P5C0798X  P5D0049X through P5D0051X  P5D0146X through P5D0148X  P5E0261X through P5E0262X  P5F0158X through P5F0161X  INDIVIDUAL LOT NUMBERS (in addition to ranges) N3F0260RX  N3F0266RX  N3F0267RX P5C0201X P5D0538X  P5E0680X  P5E0682X  P5E0686X P5E0760X P5E0762X  P5E0765X

General and Plastic Surgery Devices

2

Yes

Worldwide Distribution - US Nationwide and the countries of Canada, Albania, ALGERIA, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Georgia, Germany, Greece, Greece, Guatemala, Honduras, Hungary, Iceland, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Mauritius, Mexico, Monaco, Montenegro, Morocco, Namibia, Netherlands, Nicaragua, Nigeria, Norway, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russia, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, UAE, Ukraine, United Kingdom, Uruguay, Venezuela, and Zimbabwe.

Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle || Ref: EGIAUSHORT || Product Usage: || The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue.

RANGES OF LOT NUMBERS (all lot numbers within each range are affected) Lot # starting with P3C through P5B0521X P5D0410X through P5D0411X P5D0823X through P5D0829X  P5E0080X through P5E0082X  P5E0317X through P5E0320X  P5E0322X through P5E0324X  P5F0001X through P5F0002X  INDIVIDUAL LOT NUMBERS (in addition to ranges) P5C0239X, P5C0241X, P5C0508X, P5C0510X, P5C0512X, P5C0597X P5C0599X, P5C0601X, P5C0603X, P5C0684X, P5C0803X, P5C0805X, P5C0807X. P5E0527X, P5E0529X   P5D0067X, P5D0069X , P5D0073X, P5D0170X, P5D0413X, P5D0415X ,P5D0417X, P5D0419X, P5D0447X, P5D0623X, P5D0624X ,P5D0626X, P5D0628X   P5D0630X, P5E0525X, P5F0004X, P5F0006X, P5F0008X, P5F0010X, P5F0014X, P5F0017X, P5F0019X, P5F0021X, P5F0213X, P5F0217X

General and Plastic Surgery Devices

2

Yes

Worldwide Distribution - US Nationwide and the countries of Canada, Albania, ALGERIA, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Georgia, Germany, Greece, Greece, Guatemala, Honduras, Hungary, Iceland, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Mauritius, Mexico, Monaco, Montenegro, Morocco, Namibia, Netherlands, Nicaragua, Nigeria, Norway, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russia, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, UAE, Ukraine, United Kingdom, Uruguay, Venezuela, and Zimbabwe.

Covidien Endo GIA Ultra Universal Standard Stapler Handle || Ref: EGIAUSTND || Product Usage: || The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue.

Lot numbers within each range are affected: Lot # starting with P3C through P5B0454X, P5B0468X, P5C0152X through P5E0450X.  Individual Lot Number: P5B0468X, P5E0523X, P5E0273X

General and Plastic Surgery Devices

2

Yes

Worldwide Distribution - US Nationwide and the countries of Canada, Albania, ALGERIA, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Georgia, Germany, Greece, Greece, Guatemala, Honduras, Hungary, Iceland, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Mauritius, Mexico, Monaco, Montenegro, Morocco, Namibia, Netherlands, Nicaragua, Nigeria, Norway, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russia, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, UAE, Ukraine, United Kingdom, Uruguay, Venezuela, and Zimbabwe.

Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle || Ref: EGIAUXL || Product Usage: || The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue.

Kit Lot numbers: 00B0203 00Z1924 00Z1992 00Z1993 00Z2030 00Z2062 00Z2063 00Z2072 00Z2081 00Z2090 00Z2098 00Z2117 00Z2119 00Z2121 00Z2122 00Z2123 00Z2124 00Z2129 00Z2130 00Z2133 00Z2138 00Z2139 00Z2143 00Z2145 00Z2146 00Z2147 00Z2148 00Z2150 00Z2151 00Z2152 00Z2153 00Z2154 00Z2155 00Z2159 00Z2160 00Z2161 00Z2163 00Z2164 00Z2166 00Z2167 00Z2171 00Z2172 00Z2174 00Z2175 00Z2176 00Z2177 00Z2179 00Z2181 00Z2182 00Z2183 00Z2184 00Z2187 00Z2190 00Z2191 00Z2192 00Z2193 00Z2194 00Z2198 00Z2199 00Z2200 00Z2201 00Z2208 00Z2209 00Z2211 00Z2212 00Z2213 00Z2216 00Z2217 00Z2220 00Z2221 00Z2222 00Z2223 00Z2224 00Z2225 00Z2233 00Z2234 00Z2237 00Z2243 00Z2244 00Z2245 00Z2249 00Z2252 00Z2254 00Z2255 00Z2265 00Z2268 00Z2272 00Z2273 00Z2287 00Z2289 00Z2304 00Z2305 00Z2306 00Z2312 00Z2315 00Z2321 00Z2322 00Z2323 00Z2325 00Z2326 00Z2327 00Z2328 00Z2351 00Z2352 00Z2353 00Z2367 00Z2391 00Z2392 00Z2396 00Z2432 00Z5001 00Z5001A BARIATRICRR1 BARIATRICRR5 BARIATRICRR7 ENDOBARIATRICR ENDOBARIATRICS ENDOTHORACICL ENDOTHORACICS ENDOTHORACICW THORACICRR1 00Z2363 00Z2364 00Z2387

General and Plastic Surgery Devices

2

Yes

Worldwide Distribution - US Nationwide and the countries of Canada, Albania, ALGERIA, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Georgia, Germany, Greece, Greece, Guatemala, Honduras, Hungary, Iceland, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Mauritius, Mexico, Monaco, Montenegro, Morocco, Namibia, Netherlands, Nicaragua, Nigeria, Norway, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russia, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, UAE, Ukraine, United Kingdom, Uruguay, Venezuela, and Zimbabwe.

Best Practice Kits containing certain production lots of Endo GIA Ultra Universal Stapler Handles || Product Usage: || The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue.

All lot/serial numbers are affected for both Model numbers: 39565 and 39286

Neurological Devices

3

Yes

Worldwide Distribution, including US Nationwide.

Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a neurostimulation system for treating chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.

N558983006

General Hospital and Personal Use Devices

3

Yes

Internationally to Japan.

Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.

Serial numbers ranging BAT000001 to BAT199999.

Cardiovascular Devices

3

Yes

US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and Washington D.C.

HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) || Product Usage: || Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System is designed for in-hospital and out-of-hospital settings, including transportation via fixed-wing aircraft or helicopter.

Cardiovascular Devices

3

Yes

AUSTRIA, AUSTRALIA, BELGIUM, SWITZERLAND, GERMANY, DENMARK, FRANCE, GREAT BRITAIN, HUNGARY, JAPAN, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, SWEDEN.

Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) || Product Usage: || The 2490C CareLink Home Monitors and 2020B CareLink Express Monitors are remote monitoring systems that interrogate implanted devices and transmit the data to Medtronic s CareLink Network for viewing by the physician. The data is transmitted either through an analog telephone line, a cellular connection or an internet connection.

All Heartware Controllers manufactured after September 2014. US Model No: 1400, 1401XX, 1403US.  International Model No: 1400, 1401XX, 1407XX.

Cardiovascular Devices

3

Yes

Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI and countries of Australia, Austria, Belgium, Canada, France, Germany, Lebanon, Malaysia, Sweden, Switzerland, & United Kingdom.

HeartWare Ventricular Assist System Controller || Product Usage: || For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter

All lot/serial numbers are affected for both Model numbers 37714 and 97714.

Neurological Devices

3

Yes

Worldwide Distribution

Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. || Used to treat chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.

lot: A164580

Cardiovascular Devices

3

Yes

Nationwide Distribution to LA and WI.

EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. || The Protege EverFiex" Self-expanding Peripheral Stent System is a self-expanding Nitinol stent system intended for permanent implantation. The self-expanding stent is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on a 6 F, 0.035" over-the-wire delivery system. The stent is cut from a Nitinol tube in an open lattice design, and has tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency

Serial #'s:   YDM001132A YDM091046A YDM230250A YDM287007A YDM316478A YDM338461A YDM001745A YDM092101A YDM230251A YDM287161A YDM319952A YDM338462A YDM002664A YDM096286A YDM230252A YDM287223A YDM320649A YDM338463A YDM002701A YDM100162A YDM230254A YDM287345A YDM320877A YDM338577A YDM003337A YDM102883A YDM230265A YDM287370A YDM321013A YDM339781A YDM004445A YDM102905A YDM231186A YDM287388A YDM321225A YDM339914A YDM004921A YDM110112A YDM231295A YDM287416A YDM334335A YDM340510A YDM005795A YDM127412A YDM231296A YDM287421A YDM335349A YDM340704A YDM010849A YDM127843A YDM234714A YDM287435A YDM335397A YDM358237A YDM010853A YDM128264A YDM240991A YDM289828A YDM335518A YDM359331A YDM011147A YDM141892A YDM241982A YDM289829A YDM335520A YDM359860A YDM011149A YDM144415A YDM242216A YDM291918A YDM335555A YDM362795A YDM011272A YDM150513A YDM242217A YDM291922A YDM336083A YDM363407A YDM012137A YDM150765A YDM252868A YDM291931A YDM336111A YDM366123A YDM013030A YDM150783A YDM253726A YDM292587A YDM336391A YDM366134A YDM015178A YDM150795A YDM261210A YDM292592A YDM336411A YDM366212A YDM015183A YDM150796A YDM265729A YDM292634A YDM336426A YDM367410A YDM015353A YDM150864A YDM266233A YDM295750A YDM336434A YDM368670A YDM020290A YDM157438A YDM266778A YDM297528A YDM336461A YDM369861A YDM020298A YDM157859A YDM267760A YDM298219A YDM336479A YDM369882A YDM022307A YDM167864A YDM267780A YDM302707A YDM336759A YDM369923A YDM023936A YDM179487A YDM268447A YDM303547A YDM336846A YDM369928A YDM032480A YDM182698A YDM272202A YDM303555A YDM337081A YDM369939A YDM033976A YDM183406A YDM272660A YDM304176A YDM337083A YDM370040A YDM037712A YDM184560A YDM274102A YDM304209A YDM337439A YDM371430A YDM037957A YDM184823A YDM274701A YDM315137A YDM337452A YDM371639A YDM042190A YDM186805A YDM278813A YDM315420A YDM337535A YDM371740A YDM042952A YDM194474A YDM279279A YDM315576A YDM337635A YDM371746A YDM043309A YDM194904A YDM279482A YDM315625A YDM337947A YDM371866A YDM050840A YDM195374A YDM279555A YDM315642A YDM337949A YDM371913A YDM051330A YDM196814A YDM280192A YDM315743A YDM337950A YDM371917A YDM051664A YDM199276A YDM280262A YDM315745A YDM337982A YDM371936A YDM052090A YDM199759A YDM280387A YDM315933A YDM337994A YDM371980A YDM052600A YDM200646A YDM280758A YDM315951A YDM338008A YDM372020A YDM054481A YDM200652A YDM280769A YDM316047A YDM338024A YDM372047A YDM071665A YDM208697A YDM280805A YDM316064A YDM338098A YDM372049A YDM071666A YDM209303A YDM281138A YDM316068A YDM338100A YDM372055A YDM078576A YDM210153A YDM281848A YDM316071A YDM338144A YDM372056A YDM078845A YDM211969A YDM284759A YDM316097A YDM338334A YDM372062A YDM081835A YDM213914A YDM284783A YDM316110A YDM338356A YDM372071A YDM083551A YDM217670A YDM285023A YDM316160A YDM338441A YDM372077A YDM084623A YDM221316A YDM285199A YDM316368A YDM338444A YDM404227A YDM085232A YDM221351A YDM285252A YDM316397A YDM338452A YDM086050A YDM230247A YDM285714A YDM316469A YDM338460A

Cardiovascular Devices

3

Yes

Worldwide Distribution to Austria, Belgium, China , Czech Republic , Denmark , Finland , France, Germany, Hong Kong, India , Ireland , Israel, Italy , Malaysia, Netherlands, Norway, Poland, Portugal , Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.

Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. || The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care Link Network for viewing by the physician.

lots: VA15GPJ, VA15K3N, VA15K7K

Neurological Devices

3

Yes

US: AR, CA, FL, IL MD, MO, NE, NY, OH, TN WI.

Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).

Notification is not lot specific.

Neurological Devices

3

Yes

Worldwide Distribution.

DBS Pocket Adaptor, Model 64001 and Model 64002. || The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain stimulation. The pocket adaptor is intended to be implanted with the new replacement neurostimulator in the same pocket used for the explanted neurostimulator. Implanting in the same neurostimulator pocket allows for a single-incision procedure.

model number  CMRM3122  lot number   15F30614 15F30614-A 15H10630 15K29659 16B05695  model number CMRM3133  lot number   15F18607 15G14620 15J29647 16C03706

General and Plastic Surgery Devices

2

Yes

US Nationwide Distribution

TRYX Antibacterial Envelope Rx Only || Product Usage: || Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)

model number  CMRM6122   lot number 16E03727 16E05728  model number  CMRM6133  lot number  16E02726 16E06729

General and Plastic Surgery Devices

2

Yes

US Nationwide Distribution

TRYX Absorbable Antibacterial Envelope || Product Usage: || Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)

model number  NMRM6122   lot number  16E03727 16E05728  model number  NMRM6133  lot number  16E02726 16E09730

General and Plastic Surgery Devices

2

Yes

US Nationwide Distribution

TRYX Neuro Absorbable Antibacterial Envelope || Product Usage: || Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)

Model Number 9733986-02 . All lot numbers manufactured by Medtronic Navigation are affected.

Dental Devices

2

Yes

Worldwide Distribution - US Nationwide in the state of: NY, AZ, AR, NC, CA, OH, MI, IN, MA, TX, OH, OR, CO, MO, UT, IL. and the countries of: India, Australia, and Russian Federation.

FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. || Product Usage: || The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

P239050

Orthopedic Devices

2

Yes

AR, MN,MA

RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 3R, REF 90-SRK-311300, QTY: 1, STERILE R,