Implantable cardioverter defibrillator (non-CRT)

FDA product code LWS · Class 3 · 211 devices · 69,456 reports · 663 deaths reported · 75 devices named in recalls

• EMBLEM™ MRI S-ICD A219

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  2 recalls36 deaths15,404 reports
• EMBLEM™ S-ICD A209

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  1 recall7 deaths6,788 reports
• EMBLEM™ S-ICD 3501

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  7 deaths4,936 reports
• Cobalt™ XT DR MRI SureScan™ DDPA2D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  3 recalls30 deaths1,603 reports
• ENDOTAK RELIANCE® G 0185

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  9 deaths1,632 reports
• VIGILANT™ EL ICD DR D233

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  9 deaths1,563 reports
• Evera MRI™ XT DR SureScan® DDMB1D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall35 deaths1,426 reports
• Durata™ 7122

  St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)
  27 deaths1,377 reports
• Evera MRI™ XT DR SureScan® DDMB1D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall24 deaths1,241 reports
• Gallant™ CDVRA500Q

  St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)
  2 recalls22 deaths1,164 reports
• DYNAGEN™ EL ICD DR D152

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  12 deaths1,208 reports
• Evera MRI™ XT DR SureScan® DDMB1D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  2 recalls24 deaths945 reports
• EMBLEM™ S-ICD 3401

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  5 deaths1,039 reports
• INOGEN™ EL ICD DR D142

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  6 deaths1,017 reports
• RESONATE™ EL ICD DR D433

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  4 deaths965 reports
• DYNAGEN™ EL ICD DR D153

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  4 deaths886 reports
• Evera MRI™ XT DR SureScan™ DDMB1D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall16 deaths827 reports
• Durata™ 7120

  St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)
  31 deaths857 reports
• MOMENTUM™ EL ICD DR D121

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  2 deaths850 reports
• Evera™ XT DR DDBB1D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  2 recalls22 deaths740 reports
• ENDOTAK RELIANCE® G 0184

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  7 deaths838 reports
• DYNAGEN™ EL ICD VR D150

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  8 deaths831 reports
• INOGEN™ EL ICD VR D140

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  4 deaths823 reports
• Cobalt™ DR MRI SureScan™ DDPB3D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  3 recalls14 deaths648 reports
• VIGILANT™ EL ICD VR D232

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  8 deaths750 reports
• Evera™ XT DR DDBB1D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  2 recalls21 deaths640 reports
• Cobalt™ XT VR MRI SureScan™ DVPA2D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  3 recalls5 deaths534 reports
• ENDOTAK RELIANCE® SG 0181

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  3 deaths651 reports
• SQ-RX® PULSE GENERATOR 1010

  Cameron Health, Inc. · Implantable cardioverter defibrillator (non-CRT)
  3 deaths596 reports
• Evera™ XT VR DVBB1D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  2 recalls20 deaths489 reports
• Acticor 7 VR-T DX DF4 ProMRI 429525

  BIOTRONIK SE & Co. KG · Implantable cardioverter defibrillator (non-CRT)
  6 deaths550 reports
• Inventra 7 VR-T DX DF-1 ProMRI 399436

  BIOTRONIK SE & Co. KG · Implantable cardioverter defibrillator (non-CRT)
  1 death534 reports
• EMBLEM™ S-ICD 3401

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  1 death532 reports
• Cobalt™ XT DR MRI SureScan™ DDPA2D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  5 recalls3 deaths241 reports
• RESONATE™ HF ICD DR D533

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  2 deaths462 reports
• Evera™ XT VR DVBB1D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  2 recalls9 deaths359 reports
• RESONATE™ EL ICD VR D432

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  7 deaths439 reports
• ENDOTAK RELIANCE® SG 0180

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  2 deaths436 reports
• Durata™ 7121-65

  St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)
  23 deaths429 reports
• DYNAGEN™ EL ICD VR D151

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  4 deaths413 reports
• The Q-TRAK™ Subcutaneous Electrode 3400

  Cameron Health, Inc. · Implantable cardioverter defibrillator (non-CRT)
  2 deaths394 reports
• Iperia 7 VR-T DX DF-1 ProMRI 393032

  BIOTRONIK SE & Co. KG · Implantable cardioverter defibrillator (non-CRT)
  374 reports
• Evera MRI™ XT VR SureScan® DVMB1D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  2 recalls7 deaths272 reports
• Evera™ XT DR DDBB1D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  2 recalls7 deaths268 reports
• ENDOTAK RELIANCE® G 0175

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  1 recall5 deaths314 reports
• Durata™ 7120

  St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)
  25 deaths345 reports
• Evera MRI™ XT DR SureScan® DDMB1D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall6 deaths287 reports
• ENDOTAK RELIANCE® 0158

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  1 death331 reports
• Protecta™ XT DR D314DRG

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  4 deaths329 reports
• Visa AF MRI™ VR SureScan™ DVFB1D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall4 deaths267 reports
• MOMENTUM™ EL ICD VR D120

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  2 deaths315 reports
• Intica 7 VR-T DX DF-1 ProMRI 404633

  BIOTRONIK SE & Co. KG · Implantable cardioverter defibrillator (non-CRT)
  315 reports
• Evera MRI™ XT DR SureScan® DDMB1D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall3 deaths260 reports
• INOGEN™ EL ICD DR D143

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  297 reports
• DYNAGEN™ MINI ICD DR D022

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  1 death296 reports
• Aurora EV-ICD™ MRI SureScan™ DVEA3E4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall9 deaths225 reports
• ZOOM® LATITUDE® 3120

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  4 recalls1 death65 reports
• SQ-RX® PULSE GENERATOR 1010

  Cameron Health, Inc. · Implantable cardioverter defibrillator (non-CRT)
  3 deaths262 reports
• INOGEN™ EL ICD VR D141

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  1 death248 reports
• PERCIVA™ ICD DR D413

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  3 deaths248 reports
• Evera™ S DR DDBC3D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  2 recalls7 deaths143 reports
• Cobalt™ VR MRI SureScan™ DVPB3D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  3 recalls2 deaths81 reports
• Evera™ S DR DDBC3D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  2 recalls7 deaths123 reports
• ENDOTAK RELIANCE® 0148

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  2 deaths223 reports
• Evera™ S VR DVBC3D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  2 recalls1 death120 reports
• Cobalt™ XT VR MRI SureScan™ DVPA2D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  3 recalls3 deaths68 reports
• ZOOM® LATITUDE® 3120

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  4 recalls9 reports
• ZOOM® LATITUDE® 3120

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  4 recalls4 reports
• ZOOM® LATITUDE® 3120

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  4 recalls1 report
• ZOOM® LATITUDE® 3120

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  4 recalls1 report
• Evera™ S VR DVBC3D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  2 recalls2 deaths100 reports
• ZOOM® LATITUDE® 3120

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  4 recalls0 reports
• ZOOM® LATITUDE® 3120

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  4 recalls0 reports
• ZOOM® LATITUDE® 3120

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  4 recalls0 reports
• ZOOM® LATITUDE® 3120

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  4 recalls0 reports
• Entrant™ CDVRA300Q

  St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall1 death140 reports
• DYNAGEN™ MINI ICD VR D020

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  1 death188 reports
• Visia AF™ VR DVAB1D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  2 recalls2 deaths87 reports
• Visia AF MRI™ VR SureScan™ DVFB1D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall1 death135 reports
• Evera MRI™ S DR SureScan® DDMC3D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  2 recalls3 deaths81 reports
• Durata™ 7122

  St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)
  7 deaths168 reports
• ENDOTAK RELIANCE® 0157

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  2 deaths165 reports
• ENDOTAK RELIANCE® G 0174

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  1 recall112 reports
• Ilesto 7 VR-T DX DF-1 US 383594

  BIOTRONIK SE & Co. KG · Implantable cardioverter defibrillator (non-CRT)
  1 death157 reports
• Sprint Quattro Secure MRI™ SureScan™ 694758

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 death153 reports
• RESONATE™ HF ICD VR D532

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  150 reports
• Evera™ XT DR DDBB1D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall2 deaths97 reports
• PERCIVA™ ICD VR D412

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  2 deaths143 reports
• Visia AF™ VR DVAB1D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  2 recalls1 death42 reports
• Protecta™ XT VR D314VRG

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  4 deaths134 reports
• Sprint Quattro™ MRI SureScan™ 6946M62

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 death133 reports
• INOGEN™ MINI ICD VR D010

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  2 deaths131 reports
• Evera MRI™ S DR SureScan™ DDMC3D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  2 recalls2 deaths24 reports
• Evera MRI™ S DR SureScan™ DDMC3D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall2 deaths73 reports
• Evera™ XT DR DDBB1D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall5 deaths72 reports
• Durata™ 7170-65

  St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)
  117 reports
• ENDOTAK RELIANCE® S 0138

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  116 reports
• INOGEN™ MINI ICD DR D012

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  109 reports
• Evera™ S DR DDBC3D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall1 death53 reports
• Visia AF MRI™ S VR SureScan™ DVFC3D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  2 recalls3 reports