Medtronic, Inc.

4,394 devices · 506,719 adverse event reports · 6,243 deaths reported · 1,396 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.

• Evera MRI™ XT DR SureScan™ DDMB1D1

  Pulse generator, permanent, implantable
  2 recalls9 deaths253 reports
• Percepta™ CRT-P MRI SureScan™ W1TR01

  Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  1 recall4 deaths300 reports
• Capsure®SP Novus 5092-58

  Permanent defibrillator electrodes
  3 deaths350 reports
• Claria MRI™ CRT-D SureScan™ DTMA1D4

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall9 deaths300 reports
• Claria MRI™ Quad CRT-D SureScan™ DTMA1Q1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall7 deaths289 reports
• Evera MRI™ XT DR SureScan® DDMB1D1

  Implantable cardioverter defibrillator (non-CRT)
  1 recall6 deaths287 reports
• Viva™ Quad XT CRT-D DTBA1Q1

  Programmer, pacemaker
  2 recalls6 deaths236 reports
• ACTIVA® SC 37603

  STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
  1 death330 reports
• Attain Performa™ Straight MRI SureScan™ 439878

  permanent pacemaker Electrode
  5 deaths330 reports
• Protecta™ XT DR D314DRG

  Implantable cardioverter defibrillator (non-CRT)
  4 deaths329 reports
• CapSureFix Novus MRI™ SureScan™ 5076-52

  Permanent defibrillator electrodes
  5 deaths329 reports
• Versa™ VEDR01

  Implantable pulse generator, pacemaker (non-CRT)
  10 deaths328 reports
• Cobalt™ HF CRT-D MRI SureScan™ DTPB2D1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls3 deaths178 reports
• Viva™ S CRT-D DTBB1D1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 recalls8 deaths227 reports
• NA 5071-35

  permanent pacemaker Electrode
  1 death327 reports
• MOSAIC® 305C23

  heart-valve, non-allograft tissue
  327 reports
• MOSAIC® 305C25

  heart-valve, non-allograft tissue
  2 deaths324 reports
• NA 5071-35

  permanent pacemaker Electrode
  3 deaths322 reports
• CapSure®Z Novus 5554-45

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death320 reports
• Claria MRI™ CRT-D SureScan™ DTMA1D1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall10 deaths269 reports
• SELECTSECURE™ 383059

  permanent pacemaker Electrode
  4 deaths319 reports
• SELECTSECURE™ 383069

  permanent pacemaker Electrode
  1 death318 reports
• Amplia MRI™ Quad CRT-D SureScan™ DTMB1QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall5 deaths268 reports
• FREESTYLE® FR995-27

  heart-valve, non-allograft tissue
  2 deaths318 reports
• Visa AF MRI™ VR SureScan™ DVFB1D1

  Implantable cardioverter defibrillator (non-CRT)
  1 recall4 deaths267 reports
• Claria MRI™ Quad CRT-D SureScan™ DTMA1QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 recalls4 deaths116 reports
• ATTAIN STARFIX® 419588

  Drug eluting permanent left ventricular (lv) pacemaker electrode
  5 deaths316 reports
• Sensia™ SESR01

  Pulse generator, permanent, implantable
  5 deaths315 reports
• NA 5071-53

  permanent pacemaker Electrode
  1 death312 reports
• Evera MRI™ XT DR SureScan® DDMB1D4

  Implantable cardioverter defibrillator (non-CRT)
  1 recall3 deaths260 reports
• Capsure®Z Novus 5054-52

  permanent pacemaker Electrode
  6 deaths309 reports
• Sprint Quattro Secure S MRI™ SureScan™ 6935M62

  Permanent defibrillator electrodes
  3 deaths309 reports
• CareLink SmartSync™ 24970A

  TESTER, PACEMAKER ELECTRODE FUNCTION
  308 reports
• Reveal LINQ™, Reveal® LNQ11

  DETECTOR AND ALARM, ARRHYTHMIA
  307 reports
• CapSure®SP Novus 4092-52

  permanent pacemaker Electrode
  1 death307 reports
• NA 5071-53

  permanent pacemaker Electrode
  2 deaths304 reports
• Medtronic CareLink® Programmer 2090

  Pacemaker/icd/crt non-implanted components
  3 recalls151 reports
• CapSure®Z Novus 5554-53

  permanent pacemaker Electrode
  3 deaths300 reports
• CAPSURE® SENSE 457445

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death300 reports
• Medtronic CareLink® Programmer 2090

  Programmer, pacemaker
  2 recalls198 reports
• Intellis™ Pro 977118

  Stimulator, spinal-cord, totally implanted for pain relief
  1 death297 reports
• Capsure®SP Novus 5092-52

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  4 deaths294 reports
• FREESTYLE® FR995-29

  heart-valve, non-allograft tissue
  288 reports
• FREESTYLE® FR99525

  heart-valve, non-allograft tissue
  2 deaths280 reports
• Sprint Quattro Secure S MRI™ SureScan™ 693558

  permanent pacemaker Electrode
  3 deaths278 reports
• Activa® SC 37602

  implanted subcortical electrical Stimulator (motor disorders)
  1 recall1 death228 reports
• Cobalt™ HF Quad CRT-D MRI SureScan™ DTPB2Q1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls9 deaths127 reports
• Crome™ HF Quad CRT-D MRI SureScan™ DTPC2QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 recalls1 death76 reports
• Cobalt™ DR MRI SureScan™ DDPB3D1

  Pulse generator, permanent, implantable
  3 recalls2 deaths125 reports
• Aurora EV-ICD™ MRI SureScan™ DVEA3E4

  Implantable cardioverter defibrillator (non-CRT)
  1 recall9 deaths225 reports
• Endurant® IIs ESBF3214C103E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 recalls19 deaths173 reports
• Capsure®Z Novus 5054-58

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  2 deaths273 reports
• Amplia MRI™ CRT-D SureScan™ DTMB1D4

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls4 deaths122 reports
• Percepta™ CRT-P MRI SureScan™ W1TR01

  Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  1 recall2 deaths218 reports
• Endurant® IIs ESBF3614C103E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall37 deaths214 reports
• Claria MRI™ Quad CRT-D SureScan™ DTMA1Q1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall6 deaths213 reports
• Medtronic CareLink® Programmer 2090

  Programmer, pacemaker
  3 recalls108 reports
• ATTAIN® PERFORMA™ S 459888

  permanent pacemaker Electrode
  1 death250 reports
• Adapta™ L ADDRL1

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 recall44 deaths200 reports
• RestoreULTRA™ 37712

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  249 reports
• Enterra® II 37800

  intestinal Stimulator
  1 death248 reports
• ACTIVA® SC 37602

  STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
  1 recall2 deaths197 reports
• EnVeo™ PRO ENVPRO-16-US

  Aortic valve, prosthesis, percutaneously delivered
  1 recall23 deaths197 reports
• Viva™ Quad XT CRT-D DTBA1QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 recalls2 deaths146 reports
• CapSure®SP Novus 5592-45

  permanent pacemaker Electrode
  246 reports
• Claria MRI™ Quad CRT-D SureScan™ DTMA1QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall5 deaths194 reports
• Evera™ S DR DDBC3D1

  Implantable cardioverter defibrillator (non-CRT)
  2 recalls7 deaths143 reports
• PrimeAdvanced® SureScan® MRI 97702

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  242 reports
• MOSAIC ULTRA® 305U23

  heart-valve, non-allograft tissue
  239 reports
• Adapta™ ADSR01

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  8 deaths237 reports
• CapSure®SP Novus 4592-45

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  2 deaths237 reports
• Endurant® IIs ESBF2514C103E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 recalls18 deaths136 reports
• Amplia MRI™ CRT-D SureScan™ DTMB1D1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls1 death85 reports
• CAPSUREFIX® 5568-45

  Permanent defibrillator electrodes
  2 deaths235 reports
• MOSAIC ULTRA® 305U25

  heart-valve, non-allograft tissue
  1 death234 reports
• Sprint Quattro® 6944-58

  Permanent defibrillator electrodes
  6 deaths233 reports
• Medtronic CareLink® Programmer 2090AA4

  Pacemaker/icd/crt non-implanted components
  3 recalls82 reports
• CapSureFix Novus MRI™ SureScan™ 5076-45

  Permanent defibrillator electrodes
  2 deaths232 reports
• Cobalt™ VR MRI SureScan™ DVPB3D1

  Implantable cardioverter defibrillator (non-CRT)
  3 recalls2 deaths81 reports
• Advisa SR MRI™ SureScan™ A3SR01

  Pulse generator, permanent, implantable
  16 deaths230 reports
• Adapta® ADDR01

  Pulse generator, permanent, implantable
  7 deaths229 reports
• OmniaSecure™ MRI SureScan™ 3930M74

  Permanent defibrillator electrodes
  3 deaths228 reports
• Adapta™ L ADDRL1

  Pulse generator, permanent, implantable
  1 recall38 deaths177 reports
• Amplia MRI™ Quad CRT-D SureScan™ DTMB1QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall2 deaths177 reports
• CAPSUREFIX® NOVUS 407652

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death224 reports
• Evera™ S DR DDBC3D4

  Implantable cardioverter defibrillator (non-CRT)
  2 recalls7 deaths123 reports
• Visia AF MRI™ VR SureScan™ DVFB1D4

  Pulse generator, permanent, implantable
  1 recall2 deaths173 reports
• Percept™ PC BrainSense™ B35200

  Stimulator, electrical, implanted, for parkinsonian tremor
  222 reports
• Evera™ S VR DVBC3D4

  Implantable cardioverter defibrillator (non-CRT)
  2 recalls1 death120 reports
• Amplia MRI™ Quad CRT-D SureScan™ DTMB1Q1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls2 deaths68 reports
• Cobalt™ XT VR MRI SureScan™ DVPA2D1

  Implantable cardioverter defibrillator (non-CRT)
  3 recalls3 deaths68 reports
• Claria MRI™ CRT-D SureScan™ DTMA1D1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls63 reports
• Adapta™ ADDR01

  Implantable pulse generator, pacemaker (non-CRT)
  1 recall47 deaths161 reports
• Compia MRI™ Quad CRT-D SureScan™ DTMC1QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls2 deaths59 reports
• CAPSUREFIX® 5568-53

  Permanent defibrillator electrodes
  1 death209 reports
• Capsure® EPI 4965-35

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  207 reports
• Visia AF MRI™ VR SureScan™ DVFB1D1

  Pulse generator, permanent, implantable
  2 recalls1 death106 reports
• DLP™ 77010

  Catheter, cannula and tubing, vascular, cardiopulmonary bypass
  1 recall154 reports
• CapSure Sense® 457445

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  202 reports
• Crome™ DR MRI SureScan™ DDPC3D4

  Pulse generator, permanent, implantable
  3 recalls1 death52 reports