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.
- Sterling™ H74939031506010CATHETER, PERCUTANEOUS61 reports
- WallFlex™ Esophageal M00516900PROSTHESIS, ESOPHAGEAL1 recall11 reports
- NephroMax Kit M0062101600CATHETER, NEPHROSTOMY1 recall11 reports
- NC Emerge® H7493926712400Catheters, transluminal coronary angioplasty, percutaneous1 recall11 reports
- TACTRA 720080-01PROSTHESIS, PENILE61 reports
- Agile™ Esophageal M00517760PROSTHESIS, ESOPHAGEAL1 recall10 reports
- AMS 700 CXR 72404011Prosthesis, Penis, Inflatable60 reports
- Carotid WALLSTENT® M001719020STENT, CAROTID1 recall10 reports
- Interlock™-35 M001363610Device, Vascular, for Promoting Embolization60 reports
- WATCHMAN® Access System M635TU10060System, appendage closure, left atrial2 deaths60 reports
- Expect Pulmonary M00558220BRONCHOSCOPE (FLEXIBLE OR RIGID)60 reports
- NA M00505550Endoscopic tissue approximation device1 recall9 reports
- ACUITY™ Spiral 4591Implantable pulse generator, pacemaker (non-CRT)59 reports
- ENDOTAK RELIANCE® S 0137Implantable cardioverter defibrillator (non-CRT)59 reports
- IMAGER™ II M001314050CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall1 death9 reports
- CAPTIVATOR M00562370SNARE, FLEXIBLE1 recall9 reports
- WallFlex™ Esophageal M00516950PROSTHESIS, ESOPHAGEAL1 recall1 death9 reports
- WallFlex™ Esophageal M00516720PROSTHESIS, ESOPHAGEAL1 recall9 reports
- Carotid WALLSTENT® M001719050STENT, CAROTID1 recall9 reports
- MUSTANG™ H74939171051070CATHETER, BILIARY, DIAGNOSTIC59 reports
- Coyote™ H74939185401510CATHETER, PERCUTANEOUS59 reports
- CRE™ PRO M00558650CATHETER, BILIARY, DIAGNOSTIC59 reports
- Emerge™ H7493918915150Catheters, transluminal coronary angioplasty, percutaneous1 recall9 reports
- Emerge™ H7493918915350Catheters, transluminal coronary angioplasty, percutaneous1 recall1 death9 reports
- SYNERGY™ H7493926038350Coronary drug-eluting stent7 deaths59 reports
- AngioJet® Ultra 5000A 105650-001RCATHETER, CORONARY, ATHERECTOMY1 recall9 reports
- ROTAPRO™ H749394671750CATHETER, CORONARY, ATHERECTOMY1 death59 reports
- ENDOTAK RELIANCE® G 0187Implantable cardioverter defibrillator (non-CRT)1 recall8 reports
- AMS 800 Artificial Urinary Sphincter 72400163Device, Incontinence, Mechanical/Hydraulic58 reports
- IceRod® 1.5 MRI 90° Cryoablation Needle FPRPR3195Unit, Cryosurgical, Accessories1 recall8 reports
- Sterling™ H74939032504080CATHETER, PERCUTANEOUS58 reports
- Expo™ H74908526021CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall8 reports
- IMAGER™ II M001314060CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall8 reports
- Encore 26 M0067101140Syringe, Balloon Inflation, Exempt1 recall8 reports
- Sterling™ H74939031806010CATHETER, PERCUTANEOUS1 death58 reports
- Dreamtome™ RX 49 M00584000Unit, electrosurgical, endoscopic (with or without accessories)1 recall8 reports
- Dreamtome™ RX 49 M00584010Unit, electrosurgical, endoscopic (with or without accessories)1 recall8 reports
- Advanix™ Biliary M00534330CATHETER, BILIARY, DIAGNOSTIC3 deaths58 reports
- OptiCross H749518120Catheter, ultrasound, intravascular3 deaths58 reports
- NC Emerge® H7493926712320Catheters, transluminal coronary angioplasty, percutaneous1 recall8 reports
- ELUVIA™ H74939294701210Stent, superficial femoral artery, drug-eluting58 reports
- AMS 700™ CXR TENACIO™ Pump 72404463Prosthesis, penis, inflatable1 recall7 reports
- FARAWAVE™ M004PF41M402Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation2 deaths57 reports
- FINELINE® II Sterox 4459permanent pacemaker Electrode57 reports
- LATITUDE™ Programming System 3300Pacemaker/icd/crt non-implanted components57 reports
- AMS Ambicor 72401454Device, Impotence, Mechanical/Hydraulic57 reports
- Quantum™ Maverick™ H7493808012250Catheters, transluminal coronary angioplasty, percutaneous1 death57 reports
- IMAGER™ II M001314670CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall7 reports
- Carotid WALLSTENT® M001719060STENT, CAROTID1 recall7 reports
- FATHOM™ -14 M001508110WIRE, GUIDE, CATHETER57 reports
- NC Emerge® H7493926712270Catheters, transluminal coronary angioplasty, percutaneous1 recall7 reports
- AngioJet™ Solent™ Omni 109681-001Catheter, continuous flush2 deaths57 reports
- MAMBA™ Flex H7493928713540CATHETER, PERCUTANEOUS1 recall7 reports
- CoreDx™ M00515220Bronchoscope (flexible or rigid)57 reports
- AMS 700 LGX™ TENACIO™ Pump 72404453Prosthesis, penis, inflatable1 recall6 reports
- AMS 700 LGX™ TENACIO™ Pump 72404458Prosthesis, penis, inflatable1 recall6 reports
- VersaCross™ Access Solution VXSK0121Percutaneous atrial catheter kit1 recall6 reports
- IceSeed® 1.5 90° Cryoablation Needle FPRPR3202Unit, Cryosurgical, Accessories1 recall6 reports
- UroMax Ultra Kit M0062251210DILATOR, URETHRAL1 recall6 reports
- Expo™ H74908526961CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall6 reports
- Quantum™ Maverick™ H7493808015350Catheters, transluminal coronary angioplasty, percutaneous56 reports
- Gladiator™ Elite H74939207100470Catheter, angioplasty, peripheral, transluminal56 reports
- EndoVive Standard PEG Kit M00509050Gastrointestinal Tubes with Enteral Specific Connectors1 recall6 reports
- Comet H7493932430TRANSDUCER, PRESSURE, CATHETER TIP56 reports
- SYNERGY™ XD H7493941848400Coronary drug-eluting stent56 reports
- OBSIDIO™ M0013972001010Device, Vascular, for Promoting Embolization1 recall2 deaths5 reports
- VersaCross™ Access Solution VXSK0124Percutaneous atrial catheter kit1 recall5 reports
- IceSphere® 1.5 S 90° Cryoablation Needle FPRPR3561Unit, Cryosurgical, Accessories1 recall5 reports
- Greenfield™ M001503000FILTER, INTRAVASCULAR, CARDIOVASCULAR55 reports
- UroMax Ultra Kit M0062251220DILATOR, URETHRAL1 recall5 reports
- Maestro 4000™ Controller M00440000Cardiac ablation percutaneous catheter55 reports
- Comet™ II H74939359110Wire, guide, catheter55 reports
- Solyx™ Blue M0068507010mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling55 reports
- SpyGlass™ Discover M00546780Choledochoscope and accessories, flexible/rigid1 death55 reports
- AVVIGO™+ H7492493120I0Computer, diagnostic, programmable1 recall4 reports
- EASYTRAK® 3 IS-1 4548Implantable pulse generator, pacemaker (non-CRT)54 reports
- ADVANTIO™ K062Implantable pulse generator, pacemaker (non-CRT)54 reports
- INGENIO™ K172Implantable pulse generator, pacemaker (non-CRT)54 reports
- Conceal 720182-01Prosthesis, Penis, Inflatable54 reports
- AMS 700 LGX MS Pump 72404301Prosthesis, Penis, Inflatable54 reports
- IceRod® 1.5 Cryoablation Needle FPRPR3203Unit, Cryosurgical, Accessories1 recall4 reports
- Contour VL™ M0061801570STENT, URETERAL1 recall4 reports
- UroMax Ultra Kit M0062251370DILATOR, URETHRAL1 recall4 reports
- CRE Wireguided M00558450Colonoscope and accessories, flexible/rigid1 recall4 reports
- IMAGER™ II M001314140CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall4 reports
- IMAGER™ II M001314580CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall4 reports
- WallFlex™ Esophageal M00516920PROSTHESIS, ESOPHAGEAL1 recall4 reports
- Carotid WALLSTENT® M001719040STENT, CAROTID1 recall4 reports
- MUSTANG™ H74939171040440CATHETER, BILIARY, DIAGNOSTIC54 reports
- Coyote™ H74939186251210CATHETER, PERCUTANEOUS1 recall4 reports
- SYNERGY™ XD H7493941848300Coronary drug-eluting stent2 deaths54 reports
- AMS 700™ CXR TENACIO™ Pump 72404461Prosthesis, penis, inflatable1 recall3 reports
- AMS 700™ CXR TENACIO™ Pump 72404462Prosthesis, penis, inflatable1 recall3 reports
- AVVIGO™+ H7492493120C0Transducer, ultrasonic, diagnostic1 recall3 reports
- AMS 700 CX MS Pump 72404282Prosthesis, Penis, Inflatable53 reports
- Guider Softip™ XF H965100480CATHETER, PERCUTANEOUS1 recall3 reports
- Trapezoid RX M00510860Lithotriptor, biliary mechanical1 death53 reports
- RotaLink™ Advancer H80222782001A0CATHETER, CORONARY, ATHERECTOMY3 deaths53 reports
- UroMax Ultra Kit M0062251200DILATOR, URETHRAL1 recall3 reports
- Radial Jaw 4 M00513320FORCEPS, BIOPSY, NON-ELECTRIC1 recall3 reports