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.
- EASYTRAK® 2 IS-1 4542Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)3 deaths536 reports
- DYNAGEN™ CRT-D G151Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)3 deaths533 reports
- AMS 700 CX MS Pump 72404232-10Prosthesis, Penis, Inflatable533 reports
- EMBLEM™ S-ICD 3401Implantable cardioverter defibrillator (non-CRT)1 death532 reports
- ESSENTIO™ MRI SR L110Implantable pulse generator, pacemaker (non-CRT)1 recall2 deaths467 reports
- ENDOTAK RELIANCE® S 640272-103Permanent defibrillator electrodes3 deaths516 reports
- ACUITY™ X4 Straight 4672Implantable pulse generator, pacemaker (non-CRT)4 deaths509 reports
- Uphold™ LITE M0068318170Mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed1 recall459 reports
- MOMENTUM™ X4 CRT-D G138Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)4 deaths507 reports
- Resolution 360™ ULTRA Clip M00521400Hemostatic metal clip for the GI tract3 deaths496 reports
- AMS 800 Artificial Urinary Sphincter 72400160Device, Incontinence, Mechanical/Hydraulic487 reports
- WATCHMAN® M635WU27060System, appendage closure, left atrial45 deaths483 reports
- Trapezoid RX M00510890Lithotriptor, biliary mechanical482 reports
- LUX-Dx II+™ 60M312-100Recorder, event, implantable cardiac, (with arrhythmia detection)1 recall429 reports
- LUX-Dx™ Insertable Cardiac Monitor M301Recorder, event, implantable cardiac, (with arrhythmia detection)478 reports
- INGEVITY™ MRI 7732Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes3 deaths466 reports
- SpaceOAR VUE™ System - 10mL SV-2101Hydrogel spacer1 recall4 deaths414 reports
- RESONATE™ HF ICD DR D533Implantable cardioverter defibrillator (non-CRT)2 deaths462 reports
- WATCHMAN FLX™ M635WU50310System, appendage closure, left atrial29 deaths458 reports
- OptiCross H749518100Catheter, ultrasound, intravascular2 deaths457 reports
- WATCHMAN FLX™ Pro M635WU60310System, appendage closure, left atrial46 deaths452 reports
- EXALT™ Model D M00542420Duodenoscope and accessories, flexible/rigid4 recalls1 death252 reports
- Advantage Fit™ System M0068502110mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator451 reports
- Axios™ M00553660pancreatic stent, covered, metallic, removable3 recalls7 deaths301 reports
- ACUITY™ X4 Spiral S 4675Implantable pulse generator, pacemaker (non-CRT)2 deaths443 reports
- AMS 800 Artificial Urinary Sphincter 72404127Device, Incontinence, Mechanical/Hydraulic443 reports
- RESONATE™ EL ICD VR D432Implantable cardioverter defibrillator (non-CRT)7 deaths439 reports
- Axios™ M00553650pancreatic stent, covered, metallic, removable2 recalls5 deaths338 reports
- ESSENTIO™ SR L100Implantable pulse generator, pacemaker (non-CRT)1 recall3 deaths387 reports
- Coyote™ ES H74939135202010Catheter, angioplasty, peripheral, transluminal437 reports
- ENDOTAK RELIANCE® SG 0180Implantable cardioverter defibrillator (non-CRT)2 deaths436 reports
- OptiCross™ HD H74939352030Catheter, ultrasound, intravascular1 death436 reports
- Capio SLIM M0068318260Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse3 recalls282 reports
- ENERGEN™ ICD E143Implantable pulse generator, pacemaker (non-CRT)1 death430 reports
- WATCHMAN FLX™ Pro M635WU60240System, appendage closure, left atrial48 deaths429 reports
- AMS 700 CX MS Pump 72404231Prosthesis, Penis, Inflatable423 reports
- WATCHMAN® M635WU24060System, appendage closure, left atrial26 deaths420 reports
- FARAWAVE™ NAV M004PF41M411Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation11 deaths417 reports
- INOGEN™ CRT-D G141Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)1 death415 reports
- DYNAGEN™ EL ICD VR D151Implantable cardioverter defibrillator (non-CRT)4 deaths413 reports
- DYNAGEN™ CRT-D G150Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)2 deaths410 reports
- SpaceOAR System SO-2101Hydrogel Spacer1 recall1 death353 reports
- AMS 700 LGX MS Pump 72404257Prosthesis, Penis, Inflatable400 reports
- ENDOTAK RELIANCE® S 640273-103Permanent defibrillator electrodes2 deaths391 reports
- INGEVITY™ MRI 7736Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes1 death388 reports
- INGEVITY™ MRI 7731Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes5 deaths386 reports
- Coyote™ ES H74939135304010Catheter, angioplasty, peripheral, transluminal384 reports
- MUSTANG™ H74939171060470CATHETER, BILIARY, DIAGNOSTIC384 reports
- AMS 700 CXR 72404013Prosthesis, Penis, Inflatable381 reports
- RotaLink™ Plus H749236310030CATHETER, CORONARY, ATHERECTOMY12 deaths381 reports
- DYNAGEN™ X4 CRT-D G156Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)7 deaths379 reports
- Captivator™ COLD M00561100SNARE, NON-ELECTRICAL377 reports
- Flexiva M0068403910Powered laser surgical instrument376 reports
- IceFORCE® 2.1 CX 90° Cryoablation Needle FPRPR3602Unit, Cryosurgical, Accessories2 recalls4 deaths274 reports
- ENERGEN™ ICD E141Implantable pulse generator, pacemaker (non-CRT)368 reports
- ENDOTAK RELIANCE® G 0175Implantable cardioverter defibrillator (non-CRT)1 recall5 deaths314 reports
- CRE Fixed Wire M00558380Dilator, esophageal359 reports
- AMS 800 Artificial Urinary Sphincter 72400161Device, Incontinence, Mechanical/Hydraulic358 reports
- IntellaMap Orion™ M004RC64S0CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING6 deaths356 reports
- WATCHMAN TruSteer™ Access System M635TU90050Catheter, percutaneous1 recall28 deaths302 reports
- AMS 700 CX MS Pump 72404233Prosthesis, Penis, Inflatable342 reports
- INCEPTA™ ICD E163Implantable pulse generator, pacemaker (non-CRT)1 death339 reports
- CRE™ PRO M00558710CATHETER, BILIARY, DIAGNOSTIC1 recall284 reports
- ENDOTAK RELIANCE® 0158Implantable cardioverter defibrillator (non-CRT)1 death331 reports
- Guidezilla™ II H7493933515060CATHETER, PERCUTANEOUS1 recall3 deaths278 reports
- FINELINE® II Sterox 4480permanent pacemaker Electrode1 death324 reports
- MOMENTUM™ EL ICD VR D120Implantable cardioverter defibrillator (non-CRT)2 deaths315 reports
- AMS 700 CX MS Pump 72404238Prosthesis, Penis, Inflatable312 reports
- Autotome™ RX 44 M00545170Unit, electrosurgical, endoscopic (with or without accessories)1 recall262 reports
- Hurricane™ RX M00545920CATHETER, BILIARY, DIAGNOSTIC2 recalls211 reports
- FINELINE® II EZ Sterox 4473permanent pacemaker Electrode1 death305 reports
- ACUITY™ Spiral 4592Implantable pulse generator, pacemaker (non-CRT)1 death304 reports
- VISIONIST™ CRT-P U225Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)1 recall2 deaths253 reports
- ENERGEN™ CRT-D N140Implantable pulse generator, pacemaker (non-CRT)2 deaths301 reports
- RELIANCE 4-FRONT™ 0675Permanent defibrillator electrodes3 deaths301 reports
- INOGEN™ EL ICD DR D143Implantable cardioverter defibrillator (non-CRT)297 reports
- DYNAGEN™ MINI ICD DR D022Implantable cardioverter defibrillator (non-CRT)1 death296 reports
- WATCHMAN® M635WU30060System, appendage closure, left atrial8 deaths295 reports
- Guidezilla™ H7493924215050CATHETER, PERCUTANEOUS294 reports
- Coyote™ ES H74939135404010Catheter, angioplasty, peripheral, transluminal293 reports
- iSLEEVE™ H74939349140INTRODUCER, CATHETER1 recall12 deaths243 reports
- GreenLight HPS 0010-2090Powered Laser Surgical Instrument292 reports
- Obtryx™ System - Halo M0068505000mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator288 reports
- JETSTREAM™ XC 112266-001Catheter, peripheral, atherectomy288 reports
- Trapezoid RX M00510880Lithotriptor, biliary mechanical1 death287 reports
- Zero Tip M0063901050DISLODGER, STONE, BASKET, URETERAL, METAL287 reports
- Coyote™ ES H74939134152010Catheter, angioplasty, peripheral, transluminal279 reports
- VersaCross Connect Access Solution for FARADRIVE VXAK0041Percutaneous Atrial Catheter Kit3 deaths275 reports
- RotaLink™ Plus H749236310020CATHETER, CORONARY, ATHERECTOMY11 deaths274 reports
- FARAWAVE™ M004PF41M431Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation11 deaths272 reports
- ALTRUA™ 60 S603Implantable pulse generator, pacemaker (non-CRT)4 deaths272 reports
- WATCHMAN® M635WU33060System, appendage closure, left atrial16 deaths269 reports
- IntellaNav MiFi™ Open-Irrigated M004PMR96200catheter, percutaneous, cardiac ablation, for treatment of atrial flutter4 deaths269 reports
- WATCHMAN™ TruSeal™ Access System M635TU70020Catheter, percutaneous1 recall11 deaths217 reports
- ZOOM® LATITUDE® 3120Implantable cardioverter defibrillator (non-CRT)4 recalls1 death65 reports
- MUSTANG™ H74939171070470CATHETER, BILIARY, DIAGNOSTIC265 reports
- INTUA™ V273Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)264 reports
- INGEVITY™ MRI 7735Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes2 deaths263 reports
- AMS 700 CX MS Pump 72404237Prosthesis, Penis, Inflatable262 reports
- JETSTREAM™ XC 112264-001Catheter, peripheral, atherectomy262 reports