Implantable pulse generator, pacemaker (non-CRT)
FDA product code LWP · Class 3 · 121 devices · 84,037 reports · 1,083 deaths reported · 21 devices named in recalls
- Assurity MRI™ PM2272St. Jude Medical, Inc. · Implantable pulse generator, pacemaker (non-CRT)1 recall264 deaths16,996 reports
- ACCOLADE™ MRI EL DR L331Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls22 deaths7,984 reports
- Azure™ XT DR MRI SureScan™ W1DR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)187 deaths7,655 reports
- ACCOLADE™ MRI DR L311Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls59 deaths7,283 reports
- Azure™ XT DR MRI SureScan™ W1DR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)107 deaths5,971 reports
- ACCOLADE™ DR L301Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls6 deaths2,513 reports
- ACCOLADE™ EL DR L321Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls2 deaths1,906 reports
- ACUITY™ X4 Spiral S 4674Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)16 deaths1,975 reports
- ESSENTIO™ MRI DR L111Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls9 deaths1,790 reports
- ACUITY™ X4 Straight 4671Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)5 deaths1,875 reports
- Adapta™ ADDR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)39 deaths1,801 reports
- Advisa DR MRI™ SureScan® A2DR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)41 deaths1,758 reports
- ENDURITY MRI™ DDDRSt. Jude Medical, Inc. · Implantable pulse generator, pacemaker (non-CRT)1 recall12 deaths1,414 reports
- ESSENTIO™ DR L101Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls3 deaths1,112 reports
- ACCOLADE™ MRI SR L310Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)1 recall10 deaths1,130 reports
- Adapta™ L ADDRL1Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)20 deaths1,072 reports
- Assurity MRI™ PM1272St. Jude Medical, Inc. · Implantable pulse generator, pacemaker (non-CRT)1 recall45 deaths842 reports
- INGENIO™ K173Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)6 deaths874 reports
- ESSENTIO™ MRI EL DR L131Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls1 death774 reports
- ESSENTIO™ EL DR L121Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls758 reports
- ENERGEN™ ICD E140Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)3 deaths819 reports
- ACUITY™ X4 Spiral L 4677Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 deaths729 reports
- Azure™ S DR MRI SureScan™ W3DR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)12 deaths715 reports
- ENERGEN™ ICD E142Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)1 death705 reports
- INGENIO™ K174Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 deaths678 reports
- Azure™ XT DR MRI SureScan™ W1DR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)13 deaths654 reports
- ALTRUA™ 60 S606Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)3 deaths649 reports
- ACCOLADE™ SR L300Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)1 recall5 deaths574 reports
- INCEPTA™ ICD E160Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 deaths601 reports
- INCEPTA™ ICD E162Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)570 reports
- ADVANTIO™ K063Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 deaths557 reports
- ESSENTIO™ MRI SR L110Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)1 recall2 deaths467 reports
- ACUITY™ X4 Straight 4672Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)4 deaths509 reports
- Azure™ XT SR MRI SureScan™ W1SR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)22 deaths469 reports
- Azure™ S DR MRI SureScan™ W3DR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)2 deaths443 reports
- ACUITY™ X4 Spiral S 4675Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 deaths443 reports
- ESSENTIO™ SR L100Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)1 recall3 deaths387 reports
- Sensia™ SEDR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)10 deaths434 reports
- ENERGEN™ ICD E143Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)1 death430 reports
- ENERGEN™ ICD E141Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)368 reports
- INCEPTA™ ICD E163Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)1 death339 reports
- Versa™ VEDR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)10 deaths328 reports
- ACUITY™ Spiral 4592Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)1 death304 reports
- ENERGEN™ CRT-D N140Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 deaths301 reports
- ALTRUA™ 60 S603Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)4 deaths272 reports
- ENDURITY MRI™ SSIRSt. Jude Medical, Inc. · Implantable pulse generator, pacemaker (non-CRT)1 recall12 deaths218 reports
- ADVANTIO™ K064Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)253 reports
- INCEPTA™ ICD E161Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)236 reports
- ENERGEN™ CRT-D N141Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 deaths229 reports
- VITALIO™ K274Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)1 death214 reports
- Adapta™ ADDR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)1 recall47 deaths161 reports
- Merlin.net MN6000Cardiomems, Inc. · Implantable pulse generator, pacemaker (non-CRT)4 recalls0 reports
- Advisa DR MRI™ SureScan® A2DR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)4 deaths182 reports
- Versa™ VEDR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)1 recall19 deaths122 reports
- ACUITY™ X4 Spiral L 4678Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 deaths171 reports
- INCEPTA™ CRT-D N161Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 deaths168 reports
- ALTRUA™ 60 S602Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)1 death148 reports
- Adapta™ S ADDRS1Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)7 deaths142 reports
- EASYTRAK® 3 IS-1 4549Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)135 reports
- ALTRUA™ 60 S601Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)112 reports
- PROPONENT™ DR L201Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls9 reports
- INCEPTA™ CRT-D N160Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)1 death108 reports
- INCEPTA™ CRT-D N164Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)1 death96 reports
- Azure™ S SR MRI SureScan™ W3SR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)7 deaths86 reports
- Azure™ S SR MRI SureScan™ W3SR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)5 deaths83 reports
- VITALIO™ K273Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)68 reports
- ACUITY™ Spiral 4591Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)59 reports
- EASYTRAK® 3 IS-1 4548Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)54 reports
- ADVANTIO™ K062Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)54 reports
- INGENIO™ K172Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)54 reports
- PROPONENT™ SR L200Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)1 recall0 reports
- Azure™ S DR MRI SureScan™ W3DR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)42 reports
- Attesta™ SR MRI SureScan™ ATSR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)1 death38 reports
- PUNCTUA™ ICD E053Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)38 reports
- Sensia™ SEDR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)2 deaths36 reports
- Sensia® SESR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)1 death33 reports
- ALTRUA™ 40 S404Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)33 reports
- ALTRUA™ 20 S208Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)32 reports
- Versa® VEDR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)1 death30 reports
- PROPONENT™ EL DR L221Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)28 reports
- ALTRUA™ 40 S403Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)1 death27 reports
- ALTRUA™ 2 DR S702Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)27 reports
- PUNCTUA™ CRT-D N051Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)26 reports
- ACUITY™ Spiral 4593Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)24 reports
- Adapta™ ADSR06Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)20 reports
- NA 5846ALMedtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)18 reports
- Advisa SR MRI™ SureScan® A3SR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)1 death16 reports
- PUNCTUA™ ICD E051Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)16 reports
- ALTRUA™ 20 S203Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)14 reports
- VITALIO™ K272Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)14 reports
- Sensia™ SESR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)12 reports
- Adapta™ ADSR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)12 reports
- PUNCTUA™ ICD E052Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)9 reports
- ALTRUA™ 40 S401Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)9 reports
- Adapta™ ADSR03Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)1 death7 reports
- Attesta™ L DR MRI SureScan™ ATDRL1Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)7 reports
- ALTRUA™ 20 S201Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)7 reports
- Azure™ S SR MRI SureScan™ W3SR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)6 reports
- PUNCTUA™ ICD E050Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)6 reports
- ALTRUA™ 20 S205Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)6 reports