Boston Scientific Corporation
4,038 devices · 274,337 adverse event reports · 2,107 deaths reported · 451 devices named in recalls
Counts reflect reports that name each device's exact identifier. Larger companies sell more devices, so totals should not be read as a safety ranking.
- LATITUDE™ Programming System 3300Pacemaker/icd/crt non-implanted components141 reports
- LOTUS Edge™ Valve System H749LVSUS250Aortic valve, prosthesis, percutaneously delivered1 recall19 deaths91 reports
- AMS 700 LGX MS Pump 72404256Prosthesis, Penis, Inflatable139 reports
- Flexiva™ ID M006R8403910Powered laser surgical instrument137 reports
- RotaLink™ Plus H749236310040CATHETER, CORONARY, ATHERECTOMY3 deaths136 reports
- EASYTRAK® 3 IS-1 4549Implantable pulse generator, pacemaker (non-CRT)135 reports
- AMS 700 LGX 72404292Prosthesis, Penis, Inflatable135 reports
- INOGEN™ CRT-D G140Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)2 deaths134 reports
- ENDOTAK RELIANCE® G 0286Permanent defibrillator electrodes1 recall83 reports
- CAPTIVATOR II M00561230SNARE, FLEXIBLE1 recall83 reports
- CAPTIVATOR M00562320SNARE, FLEXIBLE2 recalls32 reports
- INOGEN™ MINI ICD VR D010Implantable cardioverter defibrillator (non-CRT)2 deaths131 reports
- Hedgehog SBD-289ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE129 reports
- RotaWire™ and wireClip™ Torquer H802232390010CATHETER, CORONARY, ATHERECTOMY2 deaths128 reports
- Hurricane™ RX M00545890CATHETER, BILIARY, DIAGNOSTIC2 recalls28 reports
- CAPTIVATOR M00562300SNARE, FLEXIBLE1 recall78 reports
- Sterling™ H74939031504010CATHETER, PERCUTANEOUS128 reports
- LUX-Dx II™ 60M302-100Recorder, event, implantable cardiac, (with arrhythmia detection)1 recall77 reports
- Capio M0068311250HOLDER, NEEDLE, GASTROENTEROLOGIC1 recall77 reports
- Coyote™ ES H74939135254010Catheter, angioplasty, peripheral, transluminal127 reports
- Extractor™ Pro RX M00547000CATHETER, BILIARY, DIAGNOSTIC1 recall1 death76 reports
- Upsylon™ M0068318200Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed126 reports
- Flexiva Pulse ID M006L8406910Powered laser surgical instrument2 recalls26 reports
- SYNERGY™ H7493926038300Coronary drug-eluting stent8 deaths124 reports
- Sterling™ H74939032504040CATHETER, PERCUTANEOUS123 reports
- Ultratome XL M00535920SNARE, FLEXIBLE122 reports
- AMS 700 LGX MS Pump 72404253-12Prosthesis, Penis, Inflatable121 reports
- CAPTIVATOR M00561310SNARE, FLEXIBLE2 recalls21 reports
- CAPTIVATOR M00562450SNARE, FLEXIBLE1 recall71 reports
- Axios™ M00553680Pancreatic stent, covered, metallic, removable2 recalls20 reports
- AMS 700 Spherical Reservoir 72404155Prosthesis, Penis, Inflatable120 reports
- CAPTIFLEX M00562420SNARE, FLEXIBLE1 recall69 reports
- LOTUS Edge™ Valve System H749LVSUS230Aortic valve, prosthesis, percutaneously delivered1 recall10 deaths69 reports
- VISIONIST™ CRT-P U226Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)2 recalls18 reports
- Sensor M0066703080STYLET FOR CATHETER, GASTRO-UROLOGY118 reports
- Coyote™ H74939185252210CATHETER, PERCUTANEOUS118 reports
- Flexiva Pulse ID M006L8406960Powered laser surgical instrument2 recalls18 reports
- AMS Ambicor 72401451Device, Impotence, Mechanical/Hydraulic117 reports
- Coyote™ ES H74939135302010Catheter, angioplasty, peripheral, transluminal1 death117 reports
- ENDOTAK RELIANCE® S 0138Implantable cardioverter defibrillator (non-CRT)116 reports
- XXL™ Esophageal M001145590Dilator, esophageal116 reports
- OptiCross™ HD H74939352040Catheter, ultrasound, intravascular3 deaths116 reports
- MOMENTUM™ CRT-D G126Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)115 reports
- Sterling™ H74939031704010CATHETER, PERCUTANEOUS115 reports
- TRUEtome 44 M00584180Unit, electrosurgical, endoscopic (with or without accessories)115 reports
- AMS 700™ CX TENACIO™ Pump 72404432Prosthesis, penis, inflatable1 recall64 reports
- OverStitch™ M00505530Endoscopic tissue approximation device1 recall64 reports
- Orca™ SUV-617Endoscope Channel Accessory1 recall64 reports
- rezum M006D2201-0032Unit, electrosurgical, endoscopic (with or without accessories)1 death113 reports
- Axios™ M00553690Pancreatic stent, covered, metallic, removable2 recalls13 reports
- Greenfield™ M001505010FILTER, INTRAVASCULAR, CARDIOVASCULAR113 reports
- ALTRUA™ 60 S601Implantable pulse generator, pacemaker (non-CRT)112 reports
- NaviFlex™ RX Delivery System M00533560CATHETER, BILIARY, DIAGNOSTIC112 reports
- OrcaPod™ SUV-629Endoscope channel accessory112 reports
- AMS 800 Artificial Urinary Sphincter 72400162Device, Incontinence, Mechanical/Hydraulic111 reports
- RotaLink™ Burr H802227680020CATHETER, CORONARY, ATHERECTOMY4 deaths111 reports
- Maverick²™ H7493892815250Catheters, transluminal coronary angioplasty, percutaneous111 reports
- V-14™ Control Wire™ H74939216730010WIRE, GUIDE, CATHETER111 reports
- WATCHMAN® Access System M635TU40060System, appendage closure, left atrial4 deaths111 reports
- FilterWire EZ™ H749201001900Temporary Coronary Saphenous Vein Bypass Graft for Embolic Protection110 reports
- Coyote™ ES H74939134204010Catheter, angioplasty, peripheral, transluminal110 reports
- CRE™ PRO M00558680CATHETER, BILIARY, DIAGNOSTIC1 recall60 reports
- INOGEN™ MINI ICD DR D012Implantable cardioverter defibrillator (non-CRT)109 reports
- PROPONENT™ DR L201Implantable pulse generator, pacemaker (non-CRT)2 recalls9 reports
- Sterling™ H74939032604040CATHETER, PERCUTANEOUS109 reports
- Renegade™ HI-FLO™ Kit M001183020Catheter, continuous flush109 reports
- Flexiva Pulse M006L8405960Powered laser surgical instrument2 recalls9 reports
- INCEPTA™ CRT-D N160Implantable pulse generator, pacemaker (non-CRT)1 death108 reports
- CRE Wireguided M00558500Dilator, esophageal1 recall58 reports
- SENSATION Short Throw M00560310SNARE, FLEXIBLE1 recall58 reports
- Coyote™ H74939185201510CATHETER, PERCUTANEOUS108 reports
- Coyote™ ES H74939135402010Catheter, angioplasty, peripheral, transluminal107 reports
- EkoSonic® 6779-002Catheter, Continuous Flush1 recall4 deaths56 reports
- IceFORCE™ 2.1 CX L 90° Cryoablation Needle FPRPR3618Unit, Cryosurgical, Accessories2 recalls6 reports
- SYNERGY™ H7493926016300Coronary drug-eluting stent7 deaths106 reports
- AMS 700 Spherical Reservoir 72404161Prosthesis, Penis, Inflatable105 reports
- Sterling™ H74939031804010CATHETER, PERCUTANEOUS105 reports
- FATHOM™ -16 M001509100WIRE, GUIDE, CATHETER1 death105 reports
- WATCHMAN FLX™ Pro M635WU60400System, appendage closure, left atrial10 deaths104 reports
- Encore™ 26 M001151050Syringe, balloon inflation1 recall54 reports
- Emerge™ H7493918912200Catheters, transluminal coronary angioplasty, percutaneous1 recall3 deaths54 reports
- Emerge™ H7493918915200Catheters, transluminal coronary angioplasty, percutaneous1 recall1 death54 reports
- Guidezilla™ II H74939335150610CATHETER, PERCUTANEOUS2 deaths104 reports
- IceFORCE® 2.1 CX Cryoablation Needle FPRPR3604Unit, Cryosurgical, Accessories2 recalls3 reports
- Expo™ H749085263011CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls3 reports
- Guidezilla™ II H7493933515070CATHETER, PERCUTANEOUS1 recall53 reports
- XXL™ Esophageal M001145520Dilator, esophageal102 reports
- Guider Softip™ XF H965100440CATHETER, PERCUTANEOUS2 recalls2 reports
- Hurricane™ RX M00545910CATHETER, BILIARY, DIAGNOSTIC2 recalls2 reports
- Hurricane™ RX M00545930CATHETER, BILIARY, DIAGNOSTIC2 recalls2 reports
- Obtryx™ System - Curved M0068504000mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator102 reports
- MUSTANG™ H74939171120470CATHETER, BILIARY, DIAGNOSTIC102 reports
- WATCHDOG™ H74939343A020Wire, guide, catheter2 recalls2 reports
- IcePearl™ 2.1 CX L 90° Cryoablation Needle FPRPR3617Unit, Cryosurgical, Accessories2 recalls1 report
- Expo™ H74908526501CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls1 report
- Hurricane™ RX M00545950CATHETER, BILIARY, DIAGNOSTIC2 recalls1 report
- RX Cholangiogram Kit M00575360Endoscopic Cholangiogram Kit2 recalls1 report
- IceSeed® Prostate Cryoablation Kit / Presice® System FPRPR4518Unit, Cryosurgical, Accessories2 recalls0 reports
- IcePearl® 2.1 CX Cryoablation Needle FPRPR3603Unit, Cryosurgical, Accessories2 recalls0 reports
- IceFORCE® 2.1 CX Prostate Cryoablation Kit / Visual-ICE® System FPRPR3605Unit, Cryosurgical, Accessories2 recalls0 reports