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.
- RELIANCE 4-FRONT™ 0676Permanent defibrillator electrodes261 reports
- WATCHMAN FLX™ M635WU50200System, appendage closure, left atrial18 deaths254 reports
- ADVANTIO™ K064Implantable pulse generator, pacemaker (non-CRT)253 reports
- FINELINE® II Sterox 4479permanent pacemaker Electrode1 death252 reports
- WATCHMAN FLX™ Pro M635WU60350System, appendage closure, left atrial29 deaths250 reports
- INOGEN™ EL ICD VR D141Implantable cardioverter defibrillator (non-CRT)1 death248 reports
- PERCIVA™ ICD DR D413Implantable cardioverter defibrillator (non-CRT)3 deaths248 reports
- Solyx™ SIS System M0068507000mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling248 reports
- ACUITY™ Steerable 4555Permanent defibrillator electrodes2 deaths247 reports
- Capio SLIM M0068318250Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse1 recall196 reports
- Axios™ M00553640pancreatic stent, covered, metallic, removable2 recalls2 deaths142 reports
- EXALT™ Model D M0054242CE0Duodenoscope and accessories, flexible/rigid4 recalls1 death38 reports
- TRUEtome 44 M00584170Unit, electrosurgical, endoscopic (with or without accessories)237 reports
- INCEPTA™ ICD E161Implantable pulse generator, pacemaker (non-CRT)236 reports
- CAPTIFLEX M00562400SNARE, FLEXIBLE3 recalls85 reports
- AMS 700 CXR 72404014Prosthesis, Penis, Inflatable233 reports
- WATCHMAN FLX™ M635WU50350System, appendage closure, left atrial12 deaths231 reports
- ENERGEN™ CRT-D N141Implantable pulse generator, pacemaker (non-CRT)2 deaths229 reports
- SENSATION Short Throw M00562670SNARE, FLEXIBLE1 recall178 reports
- ENDOTAK RELIANCE® 0148Implantable cardioverter defibrillator (non-CRT)2 deaths223 reports
- SENSATION Short Throw M00562650SNARE, FLEXIBLE1 recall173 reports
- AMS 800 Artificial Urinary Sphincter 72404133Device, Incontinence, Mechanical/Hydraulic220 reports
- CRE Fixed Wire M00558370Dilator, esophageal219 reports
- WATCHMAN® M635WU21060System, appendage closure, left atrial11 deaths219 reports
- IceRod® 1.5 CX 90° Cryoablation Needle FPRPR3533Unit, Cryosurgical, Accessories1 recall168 reports
- RX Locking Device and Biopsy Cap M00545260Endoscope channel accessory216 reports
- WallFlex Biliary M00570370Biliary stent system for benign strictures1 recall3 deaths166 reports
- Dreamtome™ RX 44 M00584040Unit, electrosurgical, endoscopic (with or without accessories)1 recall165 reports
- VITALIO™ K274Implantable pulse generator, pacemaker (non-CRT)1 death214 reports
- AMS 700 CXR 72404012Prosthesis, Penis, Inflatable212 reports
- MUSTANG™ H74939171050470CATHETER, BILIARY, DIAGNOSTIC212 reports
- ZOOM® LATITUDE® 3120Implantable cardioverter defibrillator (non-CRT)4 recalls9 reports
- Hurricane™ RX M00545940CATHETER, BILIARY, DIAGNOSTIC2 recalls109 reports
- Ultratome XL M00535900SNARE, FLEXIBLE205 reports
- ROTAPRO™ H749394671500CATHETER, CORONARY, ATHERECTOMY7 deaths205 reports
- ZOOM® LATITUDE® 3120Implantable cardioverter defibrillator (non-CRT)4 recalls4 reports
- Maverick²™ H7493892815200Catheters, transluminal coronary angioplasty, percutaneous1 death203 reports
- MUSTANG™ H74939171100470CATHETER, BILIARY, DIAGNOSTIC203 reports
- MUSTANG™ H74939171060440CATHETER, BILIARY, DIAGNOSTIC202 reports
- INOGEN™ X4 CRT-D G146Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)6 deaths201 reports
- ZOOM® LATITUDE® 3120Implantable cardioverter defibrillator (non-CRT)4 recalls1 report
- ZOOM® LATITUDE® 3120Implantable cardioverter defibrillator (non-CRT)4 recalls1 report
- ZOOM® LATITUDE® 3120Implantable cardioverter defibrillator (non-CRT)4 recalls0 reports
- ZOOM® LATITUDE® 3120Implantable cardioverter defibrillator (non-CRT)4 recalls0 reports
- ZOOM® LATITUDE® 3120Implantable cardioverter defibrillator (non-CRT)4 recalls0 reports
- ZOOM® LATITUDE® 3120Implantable cardioverter defibrillator (non-CRT)4 recalls0 reports
- Coyote™ H74939185202210Catheter, angioplasty, peripheral, transluminal200 reports
- CAPTIVATOR II M00561220SNARE, NON-ELECTRICAL1 recall150 reports
- Obtryx™ II System - Halo M0068505110mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator1 death196 reports
- MANTIS™ Clip M00521420Hemostatic metal clip for the GI tract195 reports
- Alliance II M00550600Syringe, balloon inflation191 reports
- CRE™ PRO M00558700CATHETER, BILIARY, DIAGNOSTIC1 recall139 reports
- DYNAGEN™ MINI ICD VR D020Implantable cardioverter defibrillator (non-CRT)1 death188 reports
- ENROUTE Transcarotid Neuroprotection System FG12531Temporary Carotid Catheter For Embolic Capture1 recall2 deaths137 reports
- AMS 800 Artificial Urinary Sphincter 72400098Device, Incontinence, Mechanical/Hydraulic1 recall137 reports
- MUSTANG™ H74939171061070CATHETER, BILIARY, DIAGNOSTIC187 reports
- OptiCross 18 H7493932800180Catheter, ultrasound, intravascular186 reports
- Lynx™ System M0068503000mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator181 reports
- EASYTRAK® 2 4518Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)1 death180 reports
- Sentinel CMS15-10C-USTemporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures2 deaths179 reports
- IcePearl® 2.1 CX 90° Cryoablation Needle FPRPR3601Unit, Cryosurgical, Accessories2 recalls78 reports
- Dreamtome™ RX 44 M00584050Unit, electrosurgical, endoscopic (with or without accessories)1 recall127 reports
- OptiCross™ 6 HD H74939354080Catheter, ultrasound, intravascular4 deaths177 reports
- AMS 700 LGX MS Pump 72404253Prosthesis, Penis, Inflatable174 reports
- ACUITY™ X4 Spiral L 4678Implantable pulse generator, pacemaker (non-CRT)2 deaths171 reports
- CAPTIVATOR M00562340SNARE, FLEXIBLE2 recalls71 reports
- Sterling™ H74939031604010CATHETER, PERCUTANEOUS171 reports
- MUSTANG™ H74939171080470CATHETER, BILIARY, DIAGNOSTIC170 reports
- MUSTANG™ H74939171050440CATHETER, BILIARY, DIAGNOSTIC169 reports
- INCEPTA™ CRT-D N161Implantable pulse generator, pacemaker (non-CRT)2 deaths168 reports
- LOTUS Edge™ Valve System H749LVSUS270Aortic valve, prosthesis, percutaneously delivered1 recall21 deaths118 reports
- RotaWire™ Drive and wireClip™ Torquer H74939462001CATHETER, CORONARY, ATHERECTOMY1 recall3 deaths117 reports
- Flexiva™ ID TracTip M006R8403960Powered laser surgical instrument166 reports
- ENDOTAK RELIANCE® 0157Implantable cardioverter defibrillator (non-CRT)2 deaths165 reports
- CRE™ PRO M00558690CATHETER, BILIARY, DIAGNOSTIC1 recall115 reports
- ENDOTAK RELIANCE® G 0174Implantable cardioverter defibrillator (non-CRT)1 recall112 reports
- RX Cytology Brush M00545000endoscopic cytology brush161 reports
- Maverick²™ H7493892820200Catheters, transluminal coronary angioplasty, percutaneous161 reports
- Advantage™ System M0068502000mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator161 reports
- EndoVive Safety PEG Kit M00566470TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall1 death111 reports
- Hurricane™ RX M00545960CATHETER, BILIARY, DIAGNOSTIC2 recalls59 reports
- SpyGlass DS M00546650Led light source154 reports
- AMS Ambicor 72401452Device, Impotence, Mechanical/Hydraulic153 reports
- AMS 700™ CX TENACIO™ Pump 72404433Prosthesis, penis, inflatable1 recall101 reports
- V-18™ Control Wire™ M001468540WIRE, GUIDE, CATHETER1 death151 reports
- DYNAGEN™ CRT-D G154Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)1 death150 reports
- RESONATE™ HF ICD VR D532Implantable cardioverter defibrillator (non-CRT)150 reports
- TACTRA 720081-01PROSTHESIS, PENILE150 reports
- ACUITY™ Steerable 4554Permanent defibrillator electrodes149 reports
- RotaLink™ Burr H802227680030CATHETER, CORONARY, ATHERECTOMY3 deaths149 reports
- Trapezoid RX M00510870Lithotriptor, biliary mechanical149 reports
- ALTRUA™ 60 S602Implantable pulse generator, pacemaker (non-CRT)1 death148 reports
- Hydratome RX 44 M00583040Unit, electrosurgical, endoscopic (with or without accessories)1 recall98 reports
- WATCHMAN FLX™ Pro M635WU60200System, appendage closure, left atrial10 deaths147 reports
- ENDOTAK RELIANCE® SG 0282Permanent defibrillator electrodes1 recall95 reports
- AMS 700 CX MS Pump 72404234-14Prosthesis, Penis, Inflatable144 reports
- PERCIVA™ ICD VR D412Implantable cardioverter defibrillator (non-CRT)2 deaths143 reports
- ENDOTAK RELIANCE® G 0285Permanent defibrillator electrodes1 recall1 death92 reports
- LATITUDE® Communicator 6290Pacemaker/icd/crt non-implanted components142 reports
- ROTAPRO™ H749393001500CATHETER, CORONARY, ATHERECTOMY2 deaths142 reports