Device Recall Boston Scientific

Lot Number: 11712923

Gastroenterology-Urology Devices

2

No

NJ, SC, TN, VA, and WI

EndoVive Safety PEG Kits 20 F || Universal Product Number (UPN): MOO566460 || The product provides nutrition directly into the stomach of adult and pediatric patients who are unable to consume by conventional methods.

US Lot/Batch #: C71403, C71404, C71405, C71406, C71501, C71502, C71601, C71602, C72302, C72303, C72401, C72402, C72403, C72404, C72701, C72801, C72802, C72803, C72901, C72902, C72903, C72904, C73002, C73003, C73103, C73104, C73105, C73201, C73202, C73203, C73204, C73205, C73301, C73302, C73401, C73402, C73601, C73602, C73801, C74301, C74302, C74401, C74502, C74601, C74701, C80201, C80202, C80203, C80301, C80401, C80402, C80403, C80501, C80801, C80802, C81001, C81002, C81102, C81201, C81202, and C81203.   OUS Lot/Batch #: C72501, C72502, C72601, C72602, C72905, C73001, C73004, C73101, C73102, C73901, C73902, C73903, C74001, C74002, C74003, and C74101

Cardiovascular Devices

3

Yes

Worldwide Distribution: USA, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Italy, Kuwait, Luxembourg, Netherlands, Norway, Panama, Poland, Portugal, Romania, Spain, Switzerland, and Ukraine.

Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System. Material Number (UPN) M001553030, Catalog Number 55-303. [OUS Material Number (UPN) M001553000, Catalog Number 55-300]

Lot / Batch #: 7908999, 7945613, 7968042, 8002696, 8049604, 8152432, 8181321, 8188798, 8189027, 8260367, 8289723, 8343908, 8350907, 8418323, 8435607, 8506420, 8529856, 8550971, 8584215, 8620500, 8632756, 8632757, 8636509, 8644935, 8656636, 9175918, 9183100, 9200564, 9455621, 9512879, 9521733, 9535932, 9656252, 9747125, 9813152, 11043633, 11122070, 11181968, 11182772, 11194875, 11259816, 11276388, 11328172, 11342423, 11363879, 11518115, 11604154, and 11665770

Cardiovascular Devices

2

No

AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN,MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, SI, WV, and WY. OUS locations to include: Balkans, Finland, Germany, Great Britain, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Romania, Saudia Arabia, Spain, Sweden, Switzerland, and United Arab Emirates

Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917511, Catalog # 1751, Material No. [Inner Pouch Label] H74917510. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide torsional control. The guidewire has a shapeable and highly radiopaque distal platinum tip. Legal Manufacturer: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA.

Lot / Batch #: 7871050, 7874112, 7901492, 7908998, 7935372, 7942404, 7946750, 7951989, 7979004, 7987978, 8002687, 8002688, 8025772, 8049137, 8056451, 8076852, 8098810, 8100687, 8115174, 8152431, 8181521, 8181914, 8182172, 8188799, 8193187, 8196976, 8199191, 8200479, 8200913, 8250949, 8252697, 8254876, 8260512, 8267344, 8268818, 8276225, 8281144, 8290915, 8334503, 8344727, 8352846, 8355028, 8356527, 8364588, 8410167, 8410168, 8418161, 8436013, 8439527, 8487277, 8494510, 8494814, 8506052, 8517771, 8529765, 8533184, 8547526, 8547528, 8548109, 8563958, 8584214, 8599724, 8620506, 8621310, 8623982, 8624400, 8624593, 8636348, 8636397, 8636409, 8636503, 8641950, 8833124, 8844258, 8856203, 9095461, 9111353, 9115679, 9115681, 9127229, 9157914, 9161086, 9183101, 9183105, 9185694, 9185695, 9188841, 9200553, 9222896, 9255968, 9261438, 9296807, 9297103, 9320040, 9339417, 9339418, 9346642, 9346643, 9368448, 9431674, 9431675, 9431676, 9435282, 9477092, 9478619, 9506755, 9506757, 9506865, 9521490, 9521491, 9521492, 9569394, 9581945, 9581946, 9583721, 9598709, 9603497, 9605899, 9637090, 9640999, 9644150, 9656493, 9656494, 9687546, 9784975, 9804363, 9822697, 11070550, 11099161, 11129198, 11132701, 11181779, 11181961, 11194872, 11204324, 11205127, 11208660, 11210322, 11243379, 11257970, 11258088, 11279186, 11279187, 11304665, 11304666, 11314418, 11314419, 11331413, 11342422, 11364163, 11364164, 11364441, 11364625, 11367614, 11368112, 11381445, 11381446, 11381713, 11400941, 11400942, 11413485, 11416911, 11416912, 11419631, 11421390, 11441801, 11455976, 11466878, 11482433, 11485605, 11491642, 11566831, 11576501, 11576502, 11604153, 11610376, 11610377, 11631997, and 11632322.

Cardiovascular Devices

2

No

AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN,MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, SI, WV, and WY. OUS locations to include: Balkans, Finland, Germany, Great Britain, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Romania, Saudia Arabia, Spain, Sweden, Switzerland, and United Arab Emirates

Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917521, Catalog # 1752, Material No. [Inner Pouch Label] H74917520. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide torsional control. The guidewire has a shapeable and highly radiopaque distal platinum tip. Legal Manufacturer: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA.

Lot / Batch #: 8507682, 8529860, 9012874, 9249774, 9249775, and 9830636.

Cardiovascular Devices

2

No

AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN,MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, SI, WV, and WY. OUS locations to include: Balkans, Finland, Germany, Great Britain, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Romania, Saudia Arabia, Spain, Sweden, Switzerland, and United Arab Emirates

Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917531, Catalog # 1753, Material No. [Inner Pouch Label] H74917530. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide torsional control. The guidewire has a shapeable and highly radiopaque distal platinum tip. Legal Manufacturer: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA.