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.
- AVEIR™ LSP203ALeadless pacemaker6 deaths440 reports
- NA 3383STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 deaths439 reports
- Tendril™ STSDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes6 deaths433 reports
- Merlin™ 3650Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)1 recall1 death380 reports
- Quattrode™ 3166STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)429 reports
- Durata™ 7121-65Implantable cardioverter defibrillator (non-CRT)23 deaths429 reports
- Fast-Cath™ 406849INTRODUCER, CATHETER420 reports
- NT2000iX™ RFG-NT-2000GENERATOR, LESION, RADIOFREQUENCY2 recalls310 reports
- Navitor™ NVTR-27Aortic valve, prosthesis, percutaneously delivered1 recall27 deaths360 reports
- St. Jude Medical Infinity™ DBS SystemSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR406 reports
- Quattrode™ 3169STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)401 reports
- Tendril™ STPermanent defibrillator electrodes16 deaths398 reports
- Allure Quadra™ PM3242Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)18 deaths391 reports
- Entrant™ CDHFA300QDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)1 recall3 deaths341 reports
- Navitor™ NVRO-25Aortic valve, prosthesis, percutaneously delivered32 deaths385 reports
- Navitor™ NVRO-29Aortic valve, prosthesis, percutaneously delivered1 recall19 deaths318 reports
- Quadra Assura™ CD3265-40QDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)12 deaths359 reports
- Advisor™ HD Grid, Sensor Enabled™ D-AVHD-DF16CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING6 deaths358 reports
- Assurity™ PM1240Pulse generator, permanent, implantable1 recall20 deaths306 reports
- St. Jude Medical Infinity™ DBS SystemSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall10 deaths306 reports
- Merlin@home™ EX1150Pulse generator, permanent, implantable353 reports
- Eon C™ 3688STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 deaths349 reports
- Victory™ 5816implantable pacemaker Pulse-generator5 deaths347 reports
- FlexNav™ FNAV-DS-LGAortic valve, prosthesis, percutaneously delivered15 deaths347 reports
- Durata™ 7120Implantable cardioverter defibrillator (non-CRT)25 deaths345 reports
- TactiCath™ PN-004075Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation7 deaths338 reports
- MitraClip™ CDS0801-XTWMitral valve repair devices5 deaths335 reports
- FORTIFY™ CD2231-40Pulse generator, permanent, implantable4 deaths334 reports
- OPTISURE™ LDA220Q-58Permanent defibrillator electrodes19 deaths334 reports
- Agilis™ G408318INTRODUCER, CATHETER333 reports
- FORTIFY™ CD1231-40Pulse generator, permanent, implantable7 deaths333 reports
- Isoflex™ 1944-46Permanent defibrillator electrodes7 deaths329 reports
- Aveir™ LSCD201Leadless pacemaker21 deaths321 reports
- Quartet™ 1458QDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)15 deaths314 reports
- Quadra Assura™ CD3365-40CDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)9 deaths313 reports
- Infinity™ 6660STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR5 deaths312 reports
- Penta™ 3228STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 death303 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MIntroducer, catheter1 death301 reports
- Merlin™ 3330Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)6 recalls0 reports
- Navitor™ NVTR-29Aortic valve, prosthesis, percutaneously delivered1 recall28 deaths249 reports
- TactiFlex™ Sensor Enabled™ A-TFSE-DFCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall6 deaths241 reports
- Durata™ 7120Q-52Permanent defibrillator electrodes11 deaths289 reports
- Swartz™ 407453INTRODUCER, CATHETER4 deaths287 reports
- Endurity™ PM2160Pulse generator, permanent, implantable1 recall2 deaths237 reports
- TriClip™ TCDS0301-XTWTricuspid valve repair device, percutaneously delivered2 deaths287 reports
- Amplatzer™ Amulet™ 9-ACP2-007-022System, appendage closure, left atrial29 deaths285 reports
- Amplatzer™ Amulet™ 9-ACP2-010-028System, appendage closure, left atrial33 deaths284 reports
- MitraClip™ CDS0706-XTMitral valve repair devices7 deaths282 reports
- UltiPace™ LPA1231Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes3 deaths281 reports
- Navitor™ NVTR-25Aortic valve, prosthesis, percutaneously delivered21 deaths279 reports
- Fast-Cath™ 406303INTRODUCER, CATHETER1 recall226 reports
- St. Jude Medical Infinity™ DBS SystemSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall226 reports
- Proclaim™ 5STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 recall223 reports
- Fortify Assura™ CD2257-40QPulse generator, permanent, implantable4 deaths269 reports
- ENDURITY MRI™ SSIRImplantable pulse generator, pacemaker (non-CRT)1 recall12 deaths218 reports
- St. Jude Medical Infinity™ DBS SystemSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR268 reports
- OPTISURE™ LDA220Q-65Permanent defibrillator electrodes9 deaths266 reports
- St. Jude Medical Infinity™ DBS SystemSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR263 reports
- SJM CONFIRM™ DM2102RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITHOUT ARRHYTHMIA DETECTION)251 reports
- Fortify Assura™ CD1257-40QPulse generator, permanent, implantable4 deaths250 reports
- Ellipse™ CD1411-36CPulse generator, permanent, implantable14 deaths248 reports
- Aveir™ LSCD111Leadless pacemaker49 deaths248 reports
- Exclaim™ 3225STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 death246 reports
- St. Jude Medical Infinity™ DBS SystemSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR237 reports
- Assert-IQ™ DM5000Recorder, event, implantable cardiac, (without arrhythmia detection)226 reports
- TactiCath™ A-TCSE-FJCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall3 deaths174 reports
- Proclaim™ 3672Stimulator, spinal-cord, totally implanted for pain relief2 recalls121 reports
- Zephyr® DRPulse generator, permanent, implantable9 deaths219 reports
- Trifecta™ TF-23Aheart-valve, non-allograft tissue22 deaths218 reports
- Agilis™ 408310INTRODUCER, CATHETER2 deaths218 reports
- Agilis™ 408309INTRODUCER, CATHETER1 recall3 deaths166 reports
- Swift-Lock™ 1192STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)215 reports
- Accent™ DRPulse generator, permanent, implantable20 deaths214 reports
- FlexNav™ FNAV-DS-SMAortic valve, prosthesis, percutaneously delivered8 deaths212 reports
- Entrant™ CDDRA300QPacemaker/icd/crt non-implanted components1 recall2 deaths158 reports
- Lamitrode Tripole™ 3219STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 death201 reports
- Octrode™ 3189Stimulator, spinal-cord, totally implanted for pain relief197 reports
- Amplatzer™ Talisman™ 9-PFO-3025Transcatheter septal occluder1 death193 reports
- Navitor Titan™ NVRO-35Aortic valve, prosthesis, percutaneously delivered1 recall12 deaths143 reports
- Trifecta™ TF-21Aheart-valve, non-allograft tissue12 deaths191 reports
- Eon Mini™ 3788STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF191 reports
- Fortify Assura™ CD2257-40Pulse generator, permanent, implantable3 deaths190 reports
- Entrant™ CDVRA300QImplantable cardioverter defibrillator (non-CRT)1 recall1 death140 reports
- Amplatzer™ 9-ASD-MF-025Transcatheter septal occluder1 death183 reports
- St. Jude Medical Infinity™ DBS SystemSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR5 deaths178 reports
- MitraClip™ SGC0801Catheter, percutaneous2 deaths177 reports
- TactiCath™ A-TCSE-DCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation2 deaths175 reports
- TactiSys™ PN-004400Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall125 reports
- MitraClip™ CDS0706-NTMitral valve repair devices4 deaths170 reports
- Durata™ 7122Implantable cardioverter defibrillator (non-CRT)7 deaths168 reports
- Durata™ 7170Q-58Permanent defibrillator electrodes3 deaths166 reports
- NA 3341STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF165 reports
- Accent™ SR RFPulse generator, permanent, implantable12 deaths164 reports
- Zephyr™ XL SRPulse generator, permanent, implantable2 deaths161 reports
- Assurity™ PM2260Pulse generator, permanent, implantable1 recall109 reports
- Trifecta™ TFGT-23Aheart-valve, non-allograft tissue7 deaths159 reports
- Identity™ 5386implantable pacemaker Pulse-generator3 deaths154 reports
- NA 3386STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)154 reports
- TactiCath™ A-TCSE-DDCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall104 reports
- Amplatzer™ PFO OccluderTranscatheter septal occluder1 death153 reports