St. Jude Medical, Inc.
997 devices · 312,017 adverse event reports · 5,159 deaths reported · 72 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.
- Proclaim™ 3671Stimulator, spinal-cord, totally implanted for pain relief1 recall4 reports
- TriClip™ TSGC0201Catheter, percutaneous54 reports
- Amplatzer™ TorqVue™ 9-TVLP4F90/080CATHETER, PERCUTANEOUS1 recall3 reports
- Identity™ 5286implantable pacemaker Pulse-generator53 reports
- SJM CONFIRM™ DM2100RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITHOUT ARRHYTHMIA DETECTION)2 deaths53 reports
- Portico™ PRT-25Aortic valve, prosthesis, percutaneously delivered8 deaths53 reports
- Amplatzer™ Amulet™ 9-ACP2-010-034System, appendage closure, left atrial6 deaths52 reports
- Quattrode™ 3163STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)52 reports
- Current® VR RFPulse generator, permanent, implantable2 deaths52 reports
- Current™ CD2211-36QPulse generator, permanent, implantable3 deaths52 reports
- Merlin@home™ EX1100Pulse generator, permanent, implantable1 recall2 reports
- Unify Assura™ CD3257-40QDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)2 deaths52 reports
- NA 3343STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF51 reports
- SJM™ C0510PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE1 recall0 reports
- SJM™ C0914PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE1 recall0 reports
- Quattrode™ 3149STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF50 reports
- Merlin.net MN5000Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)1 recall0 reports
- Quartet™ 1456QDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)1 death49 reports
- Portico™ PRT-29Aortic valve, prosthesis, percutaneously delivered5 deaths49 reports
- Gallant™ CDDRA500TImplantable cardioverter defibrillator (non-CRT)49 reports
- MitraClip™ CDS0801-NTMitral valve repair devices1 death49 reports
- TriClip™ TCDS0801-XTTricuspid valve repair device, percutaneously delivered49 reports
- Quickflex™ 1258TDrug eluting permanent left ventricular (lv) pacemaker electrode3 deaths47 reports
- Quattrode™ 3156STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF46 reports
- Quadra Allure™ PM3542Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)46 reports
- Amplatzer™ 9-PDA-004OCCLUDER, PATENT DUCTUS, ARTERIOSUS45 reports
- WorkMate Claris™ H700977COMPUTER, DIAGNOSTIC, PROGRAMMABLE45 reports
- Amplatzer Piccolo™ 9-PDAP-05-04-LOCCLUDER, PATENT DUCTUS, ARTERIOSUS1 death45 reports
- SJM Regent™ 23AGFN-756HEART-VALVE, MECHANICAL3 deaths44 reports
- Fast-Cath™ 406136INTRODUCER, CATHETER1 death44 reports
- Quartet™ 1458QLDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)44 reports
- Sustain™ PM2134Pulse generator, permanent, implantable1 death43 reports
- Amplatzer Piccolo™ 9-PDAP-05-02-LOCCLUDER, PATENT DUCTUS, ARTERIOSUS4 deaths43 reports
- Aveir™ LSN25501Introducer, catheter5 deaths43 reports
- Amplatzer™ Amulet™ 9-ACP2-007-016System, appendage closure, left atrial3 deaths42 reports
- EP-4™ H403023Generator, pulse, pacemaker, external programmable (for electrophysiological studies only)42 reports
- Fast-Cath™ 406948INTRODUCER, CATHETER42 reports
- Promote™ CD3211-36QDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)3 deaths42 reports
- Current™ CD2211-36Pulse generator, permanent, implantable2 deaths42 reports
- TriClip™ TSGC0801Catheter, percutaneous42 reports
- Durata™ 7171Q-65Permanent defibrillator electrodes4 deaths40 reports
- Fast-Cath™ 406853INTRODUCER, CATHETER39 reports
- Octrode™ 3183STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF39 reports
- EnSite™ ENSITE-R-AMP-02Computer, diagnostic, programmable38 reports
- Volt™ PFA Sensor Enabled™ A-VOLT-01Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation2 deaths38 reports
- WorkMate Claris™ H700169Computer, diagnostic, programmable37 reports
- NA DRGDorsal root ganglion stimulator for pain relief37 reports
- Fast-Cath™ 406103INTRODUCER, CATHETER36 reports
- Eon C™ 3688STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF36 reports
- Lamitrode™ 3286STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF35 reports
- Lamitrode™ 3288STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF35 reports
- Durata™ 7121Q-52Permanent defibrillator electrodes35 reports
- Regent™ 21AGFN-756HEART-VALVE, MECHANICAL3 deaths35 reports
- EnSite™ ENSITE-DWS-01Computer, diagnostic, programmable34 reports
- Verity® ADx XL SCProgrammer, pacemaker33 reports
- FlexAbility™ A-FASE-Dcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter4 deaths33 reports
- Regent™ 23AGFN-756HEART-VALVE, MECHANICAL2 deaths33 reports
- Exclaim™ 3225STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF32 reports
- Amplatzer™ 9-ASD-MF-035Transcatheter septal occluder1 death31 reports
- Lamitrode™ 3245STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF31 reports
- Optisense™ 1999-40Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes2 deaths31 reports
- Portico™ PRT-23Aortic valve, prosthesis, percutaneously delivered5 deaths31 reports
- Amplatzer Piccolo™ 9-PDAP-04-02-LOCCLUDER, PATENT DUCTUS, ARTERIOSUS7 deaths31 reports
- Regent™ 19AGFN-756HEART-VALVE, MECHANICAL31 reports
- OPTISURE™ LDA230Q-65Permanent defibrillator electrodes2 deaths30 reports
- Ultimum™ C407699INTRODUCER, CATHETER30 reports
- Epic™ E200-31Mheart-valve, non-allograft tissue2 deaths30 reports
- Cinch™ 1194STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)29 reports
- FlexAbility™ A701125catheter, percutaneous, cardiac ablation, for treatment of atrial flutter2 deaths29 reports
- FlexAbility™ A-FASE-FJcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 death29 reports
- Gallant™ CDHFA500BPulse-generator, single chamber, sensor driven, implantable29 reports
- Fast-Cath™ 406844INTRODUCER, CATHETER28 reports
- Allure Quadra™ PM3140Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)28 reports
- Lamitrode™ 3286STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF27 reports
- Aveir™ LSL02Leadless pacemaker27 reports
- Amplatzer™ 9-PDA-006OCCLUDER, PATENT DUCTUS, ARTERIOSUS26 reports
- Identity™ 5376implantable pacemaker Pulse-generator1 death26 reports
- WorkMate Claris™ H700124COMPUTER, DIAGNOSTIC, PROGRAMMABLE26 reports
- Epic™ E200-29Mheart-valve, non-allograft tissue2 deaths26 reports
- GUARDIAN™ 6010COVER, BURR HOLE1 death25 reports
- Sustain™ PM1136Pulse generator, permanent, implantable25 reports
- Ellipse™ CD1311-36Pulse generator, permanent, implantable2 deaths25 reports
- Advisor™ D-AVSE-DF10-F15CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING25 reports
- Amplatzer™ Trevisio™ 9-ATV09F45/80Catheter, percutaneous25 reports
- Epic™ E200-33Mheart-valve, non-allograft tissue25 reports
- Amplatzer™ Talisman™ 9-PFO-3525Transcatheter septal occluder1 death25 reports
- Amplatzer™ 9-PDA-003OCCLUDER, PATENT DUCTUS, ARTERIOSUS1 death24 reports
- Amplatzer Piccolo™ 9-PDAP-04-04-LOCCLUDER, PATENT DUCTUS, ARTERIOSUS3 deaths24 reports
- SJM Regent™ 25AGFN-756HEART-VALVE, MECHANICAL2 deaths23 reports
- SJM™ Masters Series HP Gelweave Valsalva 25VAVGJ-515HEART-VALVE, MECHANICAL2 deaths23 reports
- Fast-Cath™ 406180INTRODUCER, CATHETER23 reports
- Tendril™ STSDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes23 reports
- SJM Regent™ 19AGN-751HEART-VALVE, MECHANICAL3 deaths22 reports
- Fast-Cath™ 406137INTRODUCER, CATHETER22 reports
- Lamitrode Tripole™ 3219STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF22 reports
- Current™ PFA-GEN-01Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation22 reports
- SJM™ Masters Series 27MJ-501HEART-VALVE, MECHANICAL1 death21 reports
- Identity® 5480implantable pacemaker Pulse-generator21 reports
- CPS Direct™ DS2C020CATHETER, PERCUTANEOUS2 deaths21 reports
- EnSite™ EE3000COMPUTER, DIAGNOSTIC, PROGRAMMABLE21 reports