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.
- IcePearl® 2.1 CX Prostate Cryoablation Kit / Visual-ICE® System FPRPR3606Unit, Cryosurgical, Accessories2 recalls0 reports
- Three IceFORCE ® 2.1 CX Prostate Cryoablation Kit Visual-ICE® System FPRPR3607Unit, Cryosurgical, Accessories2 recalls0 reports
- Three IcePearl® 2.1 CX Prostate Cryoablation KitVisual-ICE® System FPRPR3608Unit, Cryosurgical, Accessories2 recalls0 reports
- Expo™ H74908526511CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls0 reports
- RX Needle Knife XL M00545840Unit, electrosurgical, endoscopic (with or without accessories)100 reports
- Expo™ H74908526031CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls0 reports
- Expo™ H749085263001CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls0 reports
- RX Cholangiogram Kit M00575240Endoscopic Cholangiogram Kit2 recalls0 reports
- RX Cholangiogram Kit M00575280Endoscopic Cholangiogram Kit2 recalls0 reports
- RX Cholangiogram Kit M00575320Endoscopic Cholangiogram Kit2 recalls0 reports
- RX Cholangiogram Kit M00575380Endoscopic Cholangiogram Kit2 recalls0 reports
- RX Cholangiogram Kit M00575400Endoscopic Cholangiogram Kit2 recalls0 reports
- RX Cholangiogram Kit M00575440Endoscopic Cholangiogram Kit2 recalls0 reports
- RX Cholangiogram Kit M00575480Endoscopic Cholangiogram Kit2 recalls0 reports
- Jagtome RX 39 M00573110Unit, electrosurgical, endoscopic (with or without accessories)2 recalls0 reports
- WATCHMAN™ TruSeal™ Access System M635TU70040Catheter, percutaneous1 recall1 death50 reports
- ENDOTAK RELIANCE® SG 0283Permanent defibrillator electrodes1 recall1 death49 reports
- AMS 800 Artificial Urinary Sphincter 720133-01Device, Incontinence, Mechanical/Hydraulic99 reports
- Percuflex™ Plus M0061752530STENT, URETERAL1 death99 reports
- AMS 700 CXR MS Pump 72404263Prosthesis, Penis, Inflatable98 reports
- Interlock™-35 M001363830Device, Vascular, for Promoting Embolization98 reports
- INCEPTA™ CRT-D N164Implantable pulse generator, pacemaker (non-CRT)1 death96 reports
- CRE Wireguided M00558490Colonoscope and accessories, flexible/rigid1 recall46 reports
- NaviFlex™ Pusher M00535030CATHETER, BILIARY, DIAGNOSTIC1 recall46 reports
- Contour VL™ M0061801560STENT, URETERAL1 recall45 reports
- MUSTANG™ H74939171060410CATHETER, BILIARY, DIAGNOSTIC95 reports
- Emerge™ H7493918912250Catheters, transluminal coronary angioplasty, percutaneous1 recall45 reports
- Upsylon™ Y Mesh Kit M0068318220Gynecological laparoscopic kit1 recall44 reports
- LightTrail™ Single Use M0068F64640Powered laser surgical instrument94 reports
- CRE Fixed Wire M00558360Dilator, esophageal93 reports
- CAPTIVATOR II M00561290SNARE, FLEXIBLE1 recall43 reports
- Maverick²™ H7493892815150Catheters, transluminal coronary angioplasty, percutaneous1 death92 reports
- Interlock™-35 M001363590Device, Vascular, for Promoting Embolization92 reports
- Jagtome™ Revolution RX M00584240Unit, electrosurgical, endoscopic (with or without accessories)1 recall42 reports
- ENDOTAK RELIANCE® SG 0171Implantable cardioverter defibrillator (non-CRT)1 recall41 reports
- Genesys HTA ProCerva M006580210DEVICE, THERMAL ABLATION, ENDOMETRIAL91 reports
- ROTAPRO™ H74939309010CATHETER, CORONARY, ATHERECTOMY1 recall1 death41 reports
- ENDOTAK RELIANCE® 0275Permanent defibrillator electrodes90 reports
- AMS 700 CX MS Pump 72404236Prosthesis, Penis, Inflatable90 reports
- Jagtome RX 44 M00573040Unit, electrosurgical, endoscopic (with or without accessories)1 recall40 reports
- MUSTANG™ H74939171040470CATHETER, BILIARY, DIAGNOSTIC90 reports
- SYNERGY™ H7493926020300Coronary drug-eluting stent9 deaths90 reports
- AMS 700 LGX™ TENACIO™ Pump 72404452Prosthesis, penis, inflatable1 recall1 death39 reports
- Hydratome RX 44 M00583050Unit, electrosurgical, endoscopic (with or without accessories)1 recall39 reports
- Sterling™ H74939031606010CATHETER, PERCUTANEOUS89 reports
- ALAIR™ M005ATS25010Bronchial thermoplasty system89 reports
- MicroKnife XL M00532810Unit, electrosurgical, endoscopic (with or without accessories)88 reports
- EXALT™ M00542430Endoscopic video imaging system/component, gastroenterology-urology1 recall38 reports
- XXL™ Esophageal M001145570Dilator, esophageal87 reports
- Stone Cone M0063903200DISLODGER, STONE, FLEXIBLE87 reports
- Advantage Fit™ Blue System M0068502120mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator87 reports
- CRE Wireguided M00558480Dilator, esophageal1 recall36 reports
- Quantum™ Maverick™ H7493808012300Catheters, transluminal coronary angioplasty, percutaneous86 reports
- Interlock™-35 M001363800Device, Vascular, for Promoting Embolization86 reports
- AMS 700 LGX MS Pump 72404258Prosthesis, Penis, Inflatable85 reports
- Jagtome RX 39 M00573080Unit, electrosurgical, endoscopic (with or without accessories)1 recall35 reports
- LithoVue M0067913500Ureteroscope and accessories, flexible/rigid84 reports
- OptiCross 35 H7493932800350Transducer, ultrasonic, diagnostic1 recall34 reports
- SENSATION Short Throw M00562690SNARE, FLEXIBLE1 recall33 reports
- NC Emerge® H7493926712250Catheters, transluminal coronary angioplasty, percutaneous1 recall33 reports
- rezum M006D2201-003Unit, electrosurgical, endoscopic (with or without accessories)83 reports
- SMARTFREEZE™ M004CRBS4000Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall33 reports
- FINELINE® II EZ Sterox 4472permanent pacemaker Electrode82 reports
- AMS 800 Artificial Urinary Sphincter 72404134Device, Incontinence, Mechanical/Hydraulic82 reports
- XXL™ Esophageal M001145540Dilator, esophageal82 reports
- Coyote™ H74939185402210CATHETER, PERCUTANEOUS82 reports
- SYNERGY™ H7493926016250Coronary drug-eluting stent6 deaths82 reports
- NC Emerge® H7493926715300Catheters, transluminal coronary angioplasty, percutaneous1 recall32 reports
- EndoVive Safety PEG Kit M00509000Gastrointestinal Tubes with Enteral Specific Connectors1 recall32 reports
- WATCHMAN FXD Curve™ Access System M635TU80010Catheter, percutaneous1 recall1 death31 reports
- CRE™ PRO M00558670CATHETER, BILIARY, DIAGNOSTIC1 recall31 reports
- Habib™ EndoHPB M00500070Unit, electrosurgical, endoscopic (with or without accessories)1 recall1 death31 reports
- Sterling™ H74939032404040CATHETER, PERCUTANEOUS80 reports
- ELUVIA™ H74939294601210Stent, superficial femoral artery, drug-eluting1 death80 reports
- Maverick²™ H7493892820250Catheters, transluminal coronary angioplasty, percutaneous79 reports
- Quantum™ Maverick™ H7493808015300Catheters, transluminal coronary angioplasty, percutaneous79 reports
- WallFlex™ Esophageal M00516730PROSTHESIS, ESOPHAGEAL1 recall29 reports
- OrcaPod™ SUV-628endoscopic irrigation/suction system79 reports
- AMS 700™ CX TENACIO™ Pump 72404438Prosthesis, penis, inflatable1 recall28 reports
- ENDOTAK RELIANCE® 0147Implantable cardioverter defibrillator (non-CRT)2 deaths78 reports
- IceRod® 1.5 PLUS 90° Cryoablation Needle FPRPR3508Unit, Cryosurgical, Accessories1 recall28 reports
- IceSphere™ 1.5 CX Cryoablation Needle FPRPR3573Unit, Cryosurgical, Accessories1 recall28 reports
- Encore™ 26 Advantage Kit H74904527011Syringe, balloon inflation1 recall28 reports
- EndoVive Standard PEG Kit M00568210TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall28 reports
- IntellaNav MiFi™ Open-Irrigated M004PMR9620K20catheter, percutaneous, cardiac ablation, for treatment of atrial flutter78 reports
- Jagtome™ Revolution RX M00584260Unit, electrosurgical, endoscopic (with or without accessories)1 recall28 reports
- VersaCross Connect™ LAAC Access Solution VXAK0107Percutaneous atrial catheter kit3 deaths77 reports
- DYNAGEN™ MINI ICD DR D023Implantable cardioverter defibrillator (non-CRT)77 reports
- Coyote™ H74939185302210Catheter, angioplasty, peripheral, transluminal77 reports
- AccuTrac M0068404110Powered laser surgical instrument77 reports
- ROTAPRO™ H749394671250CATHETER, CORONARY, ATHERECTOMY3 deaths77 reports
- OptiCross™ 6 HD H74939354090Transducer, ultrasonic, diagnostic76 reports
- OBSIDIO™ M0013972101010Device, Vascular, for Promoting Embolization1 recall26 reports
- Injection Gold Probe M00560150Unit, electrosurgical, endoscopic (with or without accessories)1 death76 reports
- Encore 26 M00566670Syringe, Balloon Inflation, Exempt1 recall26 reports
- RotaWire™ Drive and wireClip™ Torquer H74939463001CATHETER, CORONARY, ATHERECTOMY1 recall26 reports
- EASYTRAK® 2 4517Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)75 reports
- AMS Ambicor 72401455Device, Impotence, Mechanical/Hydraulic75 reports
- NephroMax Kit M0062101180CATHETER, NEPHROSTOMY1 recall25 reports
- Encore™ 26 H74904526011Syringe, balloon inflation1 recall25 reports