Devices

Device Recall Boston Scientific

  • Model / Serial
    Lot Numbers: 7889255, 7892445, 7905372, 7905374, 7920200, 7920201, 7920402, 7924984, 7928220, 7928221, 7940540, 7940541, 7944156, 7944157, 7948736, 7959298, 7967031, 7967032, 7974510, 7974511, 7979467, 7987625, 7987626, 7987628, 7991050, 7996574, 7996575, 8002683, 8014023, 8014024, 8037243, 8037244, 8037245, 8037246, 8041303, 8041304, 8052776, 8056276, 8056277, 8071724, 8071725, 8075136, 8075137, 8090847, 8090848, 8090849, 8093631, 8097643, 80097646, 8111219, 8117677, 8129796, 8129797, 8135040, 8150710, 8150711, 8166095, 8166096, 8170748, 8170749, 8187006, 8187007, 8191491, 8191492, 8195575, 8206782, 8211777, 8221857, 8221858, 8226825, 8226826, 8251328, 8268292, 8284683, 8286814, 8286815, 8286816, 8290951, 8290953, 8303330, 8303331, 8306943, 8322847, 8322848, 8326864, 8338442, 8346569, 8346570, 8359761, 8359762, 8359863, 8364161, 8364162, 8381248, 8381249, 8381250, 8401049, 8401050, 8410838, 8410839, 8410840, 8423298, 8423299, 8431393, 8442256, 8442257, 8446291, 8446292, 8449737, 8463164, 8463246, 8470264, 8470590, 8470592, 8482831, 8482832, 8490451, 8502347, 8502348, 8502609, 8502727, 8502728, 8502869, 8502973, 8502974, 8502975, 8502976, 8502977, 8502978, 8502979, 8502980, 8502981, 8502982, 8503290, 8503291, 8503292, 8503293, 8503294, 8503295, 8503296, 8503297, 8507018, 8507019, 8511086, 8511087, 8521622, 8526130, 8541944, 8541945, 8551221, 8563750, 8563751, 8563752, 8567702, 8567703, 8588514, 8588516, 8591865, 8591866, 8603141, 8603142, 8620591, 8620592, 8624527, 8624528, 8645198, 8645199, 8645203, 8652468, 8652469, 8655870, 8662303, 8662304, 8662305, 8666752, 8666753, 8666754, 8671097, 8683742, 8683743, 8692107, 8692108, 8705449, 8705846, 8714060, 8714427, 8714428, 8732163, 8732165, 8736497, 8748514, 8748520, 8748521, 8752576, 8752577, 8771059, 8775285, 8789042, 8789044, 8793117, 8793118, 8819197, 8819198, 8831249, 8833912, 8833913, 8834149, 8867179, 8867180, 8871566, 8889077, 8889079, 8889080, 8893395, 8893396, 8898056, 8898057, 8913684, 8913687, 8917868, 8917869, 8931675, 8931676, 8931677, 8947925, 8968803, 8968804, 8968805, 8972725, 8972726, 9132193, 9132194, 9132195, 9132196, 9132197, 9132198, 9132199, 9132200, 9132201, 9132206, 9132207, 9132208, 9132209, 9132210, 9132211, 9132292, 9132293, 9132294, 9132295
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution --- USA and countries of Austria, Belgium, France, Czech Republic, Germany, great Britain, Greece,Ireland, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Spain, Switzerland, and Sweden.
  • Product Description
    Wallstent Endoscopic Biliary Endoprosthesis 10mm x 60mm, UPN H965430500
  • Manufacturer
    Boston Scientific Corporation
  • 1 Event

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, One Boston Scientific Place, Natick MA 01760
  • Source
    USFDA

174 devices with a similar name

Learn more about the data here

Device Recall Boston Scientific COGNIS CRTD
  • Model / Serial
    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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    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.
  • Product Description
    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.
  • Manufacturer
    Boston Scientific CRM Corp
Device Recall Boston Scientific Teligen
  • Model / Serial
    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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    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.
  • Product Description
    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.
  • Manufacturer
    Boston Scientific CRM Corp
Device Recall Boston Scientific COGNIS
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States including Guam, Puerto Rico, and U.S. - Virgin Islands. OUS to include: Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, China, Cocos (Keeling) Islands, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, Gabon, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Jordan, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, Tunisia, United Arab Emirates, United Kingdom and Venezuela.
  • Product Description
    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. the following models are not available in the US: models N106, N107, P106, P107, P108. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. || Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
  • Manufacturer
    Boston Scientific CRM Corp
Device Recall Boston Scientific TELIGEN
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States including Guam, Puerto Rico, and U.S. - Virgin Islands. OUS to include: Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, China, Cocos (Keeling) Islands, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, Gabon, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Jordan, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, Tunisia, United Arab Emirates, United Kingdom and Venezuela.
  • Product Description
    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. || Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
  • Manufacturer
    Boston Scientific CRM Corp
Device Recall Boston Scientific, Ultrathin" Diamond" Balloon Dilatation Catheters
  • Model / Serial
    12935858, 12935557, 12934317, 12934318, 12934319, 12934480
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA-AL, CA, FL, IL, MI, MS, NJ, NY, NC, PA, RI, SC, TN, VA, WI, and CANADA, JAPAN, GREAT BRITAIN, NETHERLANDS.
  • Product Description
    Boston Scientific, Ultra-thin" Diamond" Balloon Dilatation Catheters, M001164040 (DT/3-4/5/40, 16-404), M001164360 (DT/5-2/5/40, 16-436),M001164620 (DT/6-4/5/40, 16-462), Made in Ireland, Ballybrit Business Park, Galway, Ireland || Recommended for Percutaneous Transluminal Angioplasty of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
  • Manufacturer
    Boston Scientific Corporation
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