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.
- Amplatzer™ 9-VSD-MUSC-018Transcatheter septal occluder10 reports
- SJM™ SARP-28RING, ANNULOPLASTY10 reports
- SJM™ Masters Series HP Gelweave Valsalva 21VAVGJ-515HEART-VALVE, MECHANICAL2 deaths10 reports
- ENGAGE™ C408536INTRODUCER, CATHETER10 reports
- Agilis™ G408321INTRODUCER, CATHETER10 reports
- CPS DIRECT™ 410212Catheter, percutaneous10 reports
- Fast-Cath™ 406702INTRODUCER, CATHETER10 reports
- Lamitrode™ 3240STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF10 reports
- QUANTIEN™ Measurement SystemCOMPUTER, DIAGNOSTIC, PROGRAMMABLE10 reports
- Advisor™ D-AVSE-D10-F20CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 death10 reports
- Advisor™ D-AVSE-DF10-F20CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING10 reports
- EnSite™ ENSITE-FF-01Computer, diagnostic, programmable10 reports
- Epic™ E200-25Mheart-valve, non-allograft tissue1 death10 reports
- Epic™ ESP200-19heart-valve, non-allograft tissue1 death10 reports
- EnSite™ ENSITE-SRFLNK-01Computer, diagnostic, programmable10 reports
- EnSite™ ENSITE-SYSTEM-111Computer, diagnostic, programmable10 reports
- SJM Regent™ 23AGN-751HEART-VALVE, MECHANICAL9 reports
- Identity® 5180Programmer, pacemaker9 reports
- ULTIMUM™ 407832INTRODUCER, CATHETER9 reports
- ULTIMUM™ 407847INTRODUCER, CATHETER9 reports
- SJM™ Masters Series 21AECJ-502HEART-VALVE, MECHANICAL1 death9 reports
- Epic™ E100-27M-00heart-valve, non-allograft tissue1 death9 reports
- Fast-Cath™ 406701INTRODUCER, CATHETER9 reports
- Current Accel® DRPulse generator, permanent, implantable9 reports
- CPS Direct™ DS2C021CATHETER, PERCUTANEOUS1 death9 reports
- ViewFlex™ H701374SYSTEM, SIGNAL ISOLATION9 reports
- Lamitrode Tripole™ 3214STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF9 reports
- Amplatzer™ Trevisio™ 9-ATV08F45/80Catheter, percutaneous9 reports
- Masters Series™ 29MJ-501HEART-VALVE, MECHANICAL2 deaths9 reports
- Amplatzer™ 9-AVP2-018Device, Vascular, for Promoting Embolization8 reports
- SJM™ Masters SeriesHemashield™ 25CAVGJ-514 00HEART-VALVE, MECHANICAL8 reports
- SJM™ Masters Series 25MJ-501HEART-VALVE, MECHANICAL8 reports
- SJM™ RSAR-34RING, ANNULOPLASTY8 reports
- Victory® SRProgrammer, pacemaker8 reports
- ULTIMUM™ 407843INTRODUCER, CATHETER8 reports
- SJM™ 405112INTRODUCER, CATHETER8 reports
- Swartz™ 407358INTRODUCER, CATHETER8 reports
- Quattrode™ 3066STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)8 reports
- Quattrode™ 3149STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF8 reports
- Merlin@home™ EX1151Pulse generator, permanent, implantable8 reports
- SJM™ Masters Series 15MHPJ-505HEART-VALVE, MECHANICAL2 deaths8 reports
- Trifecta™ TFGT-29Aheart-valve, non-allograft tissue8 reports
- TactiCath™ A-TCSE-JCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation8 reports
- NA DAC-NTCABLE, ELECTRODE8 reports
- EnSite™ ENSITE-SEK-5-01Computer, diagnostic, programmable8 reports
- Regent™ 21AGN-751HEART-VALVE, MECHANICAL8 reports
- Rigid Saddle Ring RSAR-32RING, ANNULOPLASTY8 reports
- Epic™ EMAX-23heart-valve, non-allograft tissue8 reports
- EnSite™ ENSITE-DWS-2.0.1Computer, diagnostic, programmable8 reports
- Entrant™ CDHFA300DDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes8 reports
- EnSite™ ENSITE-DWS-04Computer, diagnostic, programmable8 reports
- Amplatzer™ 9-PDA2-03-06OCCLUDER, PATENT DUCTUS, ARTERIOSUS7 reports
- Amplatzer™ 9-PDA2-05-04OCCLUDER, PATENT DUCTUS, ARTERIOSUS7 reports
- Amplatzer™ 9-VSD-MUSC-006Transcatheter septal occluder1 death7 reports
- SJM™ Masters SeriesHemashield™ 27CAVGJ-514 00HEART-VALVE, MECHANICAL1 death7 reports
- SJM™ Masters Series 31MJ-501HEART-VALVE, MECHANICAL7 reports
- SJM™ SARP-32RING, ANNULOPLASTY7 reports
- SJM™ Masters Series HP Gelweave Valsalva 29VAVGJ-515HEART-VALVE, MECHANICAL7 reports
- ULTIMUM™ 407687INTRODUCER, CATHETER7 reports
- ULTIMUM™ 407688INTRODUCER, CATHETER7 reports
- Fast-Cath™ 406804INTRODUCER, CATHETER7 reports
- Fast-Cath™ 406962INTRODUCER, CATHETER7 reports
- Swartz™ 407452INTRODUCER, CATHETER7 reports
- Agilis™ G408320INTRODUCER, CATHETER1 death7 reports
- Current Accel® DRPulse generator, permanent, implantable7 reports
- NA RF-SE-10PROBE, RADIOFREQUENCY LESION7 reports
- EnSite Precision™ EN0020-PCOMPUTER, DIAGNOSTIC, PROGRAMMABLE7 reports
- Amplatzer™ Trevisio™ 9-ATV12F45/80Catheter, percutaneous7 reports
- Epic™ ESP200-25heart-valve, non-allograft tissue7 reports
- Amplatzer™ 9-ASD-MF-018Transcatheter septal occluder6 reports
- SJM™ Masters Series 25MECJ-502HEART-VALVE, MECHANICAL1 death6 reports
- SJM™ Masters Series 31MECJ-502HEART-VALVE, MECHANICAL6 reports
- Identity® ADx DRimplantable pacemaker Pulse-generator1 death6 reports
- Victory® 5810implantable pacemaker Pulse-generator6 reports
- Fast-Cath™ 406112INTRODUCER, CATHETER6 reports
- SJM™ Masters Series AJ-501HEART-VALVE, MECHANICAL2 deaths6 reports
- Fast-Cath™ 406362INTRODUCER, CATHETER2 deaths6 reports
- ENGAGE™ C408508INTRODUCER, CATHETER6 reports
- SJM™ Masters Series 19AECJ-502HEART-VALVE, MECHANICAL6 reports
- Wi-Box™ AO TransmitterTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY6 reports
- Livewire™ 401908CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 death6 reports
- Livewire™ 401932CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 death6 reports
- Fast-Cath™ 406333INTRODUCER, CATHETER6 reports
- SJM™ 405154INTRODUCER, CATHETER6 reports
- Swartz™ 407450INTRODUCER, CATHETER6 reports
- Swartz™ 407454INTRODUCER, CATHETER6 reports
- Exclaim™ 3224STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF6 reports
- Durata® 7131-65Implantable cardioverter defibrillator (non-CRT)6 reports
- ViewMate™ H701336System, imaging, pulsed echo, ultrasonic6 reports
- SMK™ SMK-C1010-20PROBE, RADIOFREQUENCY LESION6 reports
- NA RFDEUK-10PROBE, RADIOFREQUENCY LESION6 reports
- Tendyne™ TENDV-LP-29SProsthesis, mitral valve, percutaneously delivered1 death6 reports
- NA 405108Introducer, catheter2 deaths6 reports
- Masters Series™ 31MJ-501HEART-VALVE, MECHANICAL6 reports
- Epic™ EMAX-19heart-valve, non-allograft tissue1 death6 reports
- Amplatzer™ 9-PDA2-03-04OCCLUDER, PATENT DUCTUS, ARTERIOSUS5 reports
- Amplatzer™ 9-PDA2-04-04OCCLUDER, PATENT DUCTUS, ARTERIOSUS5 reports
- Amplatzer™ 9-SB-018Catheter, intravascular occluding, temporary5 reports
- SJM™ Masters Series HP 19AHPJ-505HEART-VALVE, MECHANICAL3 deaths5 reports
- Verity™ ADx XL SRProgrammer, pacemaker5 reports