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.
- GUARDIAN™ 6010COVER, BURR HOLE151 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-SIntroducer, catheter151 reports
- Amplatzer™ 9-ASD-MF-030Transcatheter septal occluder149 reports
- UNIFY™ CD3231-40Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)8 deaths148 reports
- TriClip™ TCDS0801-XTWTricuspid valve repair device, percutaneously delivered148 reports
- Optisure™ LDA210Permanent defibrillator electrodes6 deaths147 reports
- NA 2321STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF147 reports
- Amplatzer™ Amulet™ 9-ACP2-010-031System, appendage closure, left atrial11 deaths145 reports
- Prodigy™ 3799STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF142 reports
- OPTISURE™ LDA210Q-52Permanent defibrillator electrodes4 deaths141 reports
- Amplatzer™ Talisman™ 9-PFO-2518Transcatheter septal occluder139 reports
- Navitor™ NVRO-23Aortic valve, prosthesis, percutaneously delivered11 deaths139 reports
- TactiFlex™ Sensor Enabled™ A-TFSE-FJCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation2 recalls2 deaths37 reports
- Unify Quadra™ CD3249-40QDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)7 deaths134 reports
- Gallant™ CDHFA500DDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)1 death131 reports
- TactiCath™ Quartz 65Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation2 deaths131 reports
- Amplatzer™ Amulet™ 9-ACP2-007-020System, appendage closure, left atrial15 deaths130 reports
- Swartz™ 407449INTRODUCER, CATHETER3 deaths130 reports
- Navitor™ NVTR-23Aortic valve, prosthesis, percutaneously delivered11 deaths129 reports
- Infinity™ 5STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR2 recalls28 reports
- TriCentrus™ 3292Stimulator, spinal-cord, totally implanted for pain relief127 reports
- Ellipse™ CD2311-36QPulse generator, permanent, implantable3 deaths124 reports
- Trifecta™ TFGT-21Aheart-valve, non-allograft tissue12 deaths124 reports
- TactiCath™ A-TCSE-FCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation5 deaths122 reports
- Quickflex™ 1258TDrug eluting permanent left ventricular (lv) pacemaker electrode7 deaths121 reports
- Current™ CD1211-36QPulse generator, permanent, implantable4 deaths121 reports
- Agilis™ G408324INTRODUCER, CATHETER120 reports
- Fast-Cath™ 406143INTRODUCER, CATHETER1 recall69 reports
- Proclaim™ 7STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 recall1 death69 reports
- Cinch™ 1194STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF118 reports
- NA 3346STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)117 reports
- Durata™ 7170-65Implantable cardioverter defibrillator (non-CRT)117 reports
- Swartz™ 407439INTRODUCER, CATHETER5 deaths115 reports
- MitraClip™ CDS0801-XTMitral valve repair devices3 deaths115 reports
- Trifecta™ TF-19Aheart-valve, non-allograft tissue5 deaths110 reports
- Ellipse™ CD1311-36QPulse generator, permanent, implantable4 deaths109 reports
- Unify Assura™ CD3257-40Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)4 deaths108 reports
- Sustain™ PM2136Pulse generator, permanent, implantable107 reports
- NT1100™ RFG-NT-1100GENERATOR, LESION, RADIOFREQUENCY107 reports
- EnSite™ ENSITE-AMP-02Computer, diagnostic, programmable106 reports
- IonicRF™ RFG-IONICGenerator, lesion, radiofrequency105 reports
- Fast-Cath™ 406840INTRODUCER, CATHETER2 deaths102 reports
- NA 2311STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF102 reports
- Verity™ ADx XL DRimplantable pacemaker Pulse-generator100 reports
- Merlin™ MER3400Implantable cardioverter defibrillator (non-CRT)2 recalls0 reports
- Agilis™ G408319INTRODUCER, CATHETER97 reports
- Durata™ 7170Q-65Permanent defibrillator electrodes1 death97 reports
- Infinity™ 7STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall1 death47 reports
- Trifecta™ TF-25Aheart-valve, non-allograft tissue9 deaths96 reports
- St. Jude Medical Infinity™ DBS SystemSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR93 reports
- Endurity™ PM1160Pulse generator, permanent, implantable1 recall1 death42 reports
- ULTIMUM™ 407831INTRODUCER, CATHETER1 recall40 reports
- Zephyr® SRPulse generator, permanent, implantable4 deaths90 reports
- NA CLASSICPROBE, RADIOFREQUENCY LESION1 recall40 reports
- Microny™ 2525TPulse-generator, single chamber, sensor driven, implantable1 death88 reports
- Accent™ SRPulse generator, permanent, implantable8 deaths88 reports
- EnSite™ Velocity™ 100014514COMPUTER, DIAGNOSTIC, PROGRAMMABLE87 reports
- UNIFY™ CD3231-40QDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)2 deaths86 reports
- Fortify Assura™ CD1257-40Pulse generator, permanent, implantable2 deaths86 reports
- Quartet™ 1457QDrug eluting permanent left ventricular (lv) pacemaker electrode5 deaths86 reports
- Amplatzer™ ASDS-14F-075Catheter, percutaneous1 recall1 death35 reports
- Fast-Cath™ 406968INTRODUCER, CATHETER84 reports
- Quadra Assura™ CD3265-40Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)3 deaths83 reports
- Verity® ADx XL SRProgrammer, pacemaker81 reports
- Quattrode® 3163STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)81 reports
- Trifecta™ TFGT-25Aheart-valve, non-allograft tissue5 deaths80 reports
- Amplatzer™ 9-PDA-005OCCLUDER, PATENT DUCTUS, ARTERIOSUS79 reports
- Ellipse™ DRPulse generator, permanent, implantable1 death79 reports
- Amplatzer™ Amulet™ 9-ACP2-007-018System, appendage closure, left atrial6 deaths76 reports
- Current™ CD1211-36Pulse generator, permanent, implantable2 deaths76 reports
- NA RF-DGP-LELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall23 reports
- Durata™ 7121-60Implantable cardioverter defibrillator (non-CRT)4 deaths72 reports
- WorkMate Claris™ H700150COMPUTER, DIAGNOSTIC, PROGRAMMABLE72 reports
- Gallant™ CDHFA500TDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)1 death71 reports
- SJM Regent™ AGFN-756HEART-VALVE, MECHANICAL3 deaths70 reports
- Proclaim™ 3665STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 recall20 reports
- MitraClip™ CDS0801-NTWMitral valve repair devices1 death69 reports
- Octrode™ 3189STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF68 reports
- TactiFlex™ Sensor Enabled™ A-TFSE-FCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall18 reports
- St. Jude Medical Infinity™ DBS SystemSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall17 reports
- SJM Regent™ AGFN-756HEART-VALVE, MECHANICAL5 deaths66 reports
- Unify Quadra™ CD3249-40Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)6 deaths65 reports
- FlexAbility™ A-FASE-DFcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter6 deaths65 reports
- TactiFlex™ Sensor Enabled™ A-TFSE-DDCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall14 reports
- Infinity™ 6661STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall13 reports
- Amplatzer™ PFO OccluderTranscatheter septal occluder1 death62 reports
- TactiFlex™ Sensor Enabled™ A-TFSE-DCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall12 reports
- TriClip™ TCDS0301-XTTricuspid valve repair device, percutaneously delivered62 reports
- ANTHEM™ PM3210Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)5 deaths61 reports
- Amplatzer™ TorqVue™ 9-TVLPC4F90/080CATHETER, PERCUTANEOUS1 recall3 deaths9 reports
- Verity™ ADx XL VDRimplantable pacemaker Pulse-generator59 reports
- Durata™ 7171Q-58Permanent defibrillator electrodes58 reports
- Proclaim™ 3667STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 recall8 reports
- Portico™ PRT-27Aortic valve, prosthesis, percutaneously delivered8 deaths57 reports
- Quattrode™ 3146STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF57 reports
- Swartz™ 407362INTRODUCER, CATHETER56 reports
- Lamitrode™ 3244STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF56 reports
- Trifecta™ TFGT-19Aheart-valve, non-allograft tissue3 deaths55 reports
- Amplatzer™ TorqVue™ 9-TVLP4F90/060CATHETER, PERCUTANEOUS1 recall4 reports
- Ampere™ H700488Cardiac ablation percutaneous catheter54 reports