Implantable cardioverter defibrillator (non-CRT)

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

• Primo MRI™ DR SureScan™ DDMD3D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall52 reports
• Merlin™ MER3400

  St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)
  2 recalls0 reports
• Protecta™ DR D334DRG

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  3 deaths98 reports
• Epsila EV™ MRI SureScan™ EV240152

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  2 deaths91 reports
• ENDOTAK RELIANCE® SG 0171

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  1 recall41 reports
• Maximo® II VR D284VRC

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  2 deaths87 reports
• Evera™ XT DR DDBB1D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall1 death28 reports
• ENDOTAK RELIANCE® 0147

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  2 deaths78 reports
• DYNAGEN™ MINI ICD DR D023

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  77 reports
• Ilivia 7 VR-T DF4 ProMRI 404626

  BIOTRONIK SE & Co. KG · Implantable cardioverter defibrillator (non-CRT)
  1 death77 reports
• Evera™ S DR DDBC3D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall1 death25 reports
• Visia AF MRI™ S VR SureScan™ DVFC3D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall1 death23 reports
• Primo MRI™ DR SureScan™ DDMD3D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall22 reports
• INOGEN™ MINI ICD VR D011

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  1 death72 reports
• Durata™ 7121-60

  St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)
  4 deaths72 reports
• Iforia 7 VR-T DX DF-1 US 390090

  BIOTRONIK SE & Co. KG · Implantable cardioverter defibrillator (non-CRT)
  71 reports
• Visia AF™ VR DVAB1D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall20 reports
• LATITUDE® Communicator 6290

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  70 reports
• ENDOTAK RELIANCE® SG 0170

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  1 recall19 reports
• Evera™ XT VR DVBB1D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall18 reports
• Primo MRI™ VR SureScan™ DVMD3D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall17 reports
• Protecta™ VR D334VRG

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  2 deaths65 reports
• Protecta™ XT VR D314VRM

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

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall13 reports
• ENDOTAK RELIANCE® S 0137

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  59 reports
• Evera™ S VR DVBC3D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall8 reports
• Evera™ S VR DVBC3D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall8 reports
• ENDOTAK RELIANCE® G 0187

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  1 recall8 reports
• Evera™ S DR DDBC3D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall7 reports
• Visia AF MRI™ VR SureScan™ DVFB1D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  2 deaths57 reports
• Evera™ XT DR DDBB1D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall7 reports
• Evera™ S VR DVBC3D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall6 reports
• Primo MRI™ VR SureScan™ DVMD3D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall5 reports
• Evera™ S VR DVBC3D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall2 reports
• ENDOTAK RELIANCE® G 0176

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  1 recall2 reports
• Evera™ XT VR DVBB1D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall1 report
• Evera™ S VR DVBC3D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall1 report
• INOGEN™ MINI ICD DR D013

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  51 reports
• Evera™ XT VR DVBB1D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall0 reports
• Evera™ XT VR DVBB1D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 recall0 reports
• ENDOTAK RELIANCE® G 0177

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  1 recall0 reports
• PERCIVA™ ICD DR D401

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  49 reports
• Itrevia 7 VR-T DX DF-1 393037

  BIOTRONIK SE & Co. KG · Implantable cardioverter defibrillator (non-CRT)
  49 reports
• Gallant™ CDDRA500T

  St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)
  49 reports
• Ilivia 7 VR-T DF-1 ProMRI 404625

  BIOTRONIK SE & Co. KG · Implantable cardioverter defibrillator (non-CRT)
  48 reports
• DYNAGEN™ MINI ICD VR D021

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  44 reports
• Itrevia 7 VR-T DF4 393041

  BIOTRONIK SE & Co. KG · Implantable cardioverter defibrillator (non-CRT)
  1 death44 reports
• Rivacor 7 VR-T DF4 ProMRI 429536

  BIOTRONIK SE & Co. KG · Implantable cardioverter defibrillator (non-CRT)
  42 reports
• ENDOTAK RELIANCE® G 0186

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  1 death40 reports
• SPRINT QUATTRO SECURE® DXAC/DSP 694765

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  38 reports
• Inventra 7 VR-T DX DF-1 399437

  BIOTRONIK SE & Co. KG · Implantable cardioverter defibrillator (non-CRT)
  32 reports
• Intica Neo 7 VR-T DX DF-1 ProMRI 429559

  BIOTRONIK SE & Co. KG · Implantable cardioverter defibrillator (non-CRT)
  1 death32 reports
• Ilesto 7 VR-T DF-1 US 383578

  BIOTRONIK SE & Co. KG · Implantable cardioverter defibrillator (non-CRT)
  28 reports
• Visia AF™ VR DVAB1D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  26 reports
• NA 6721S-50

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 death26 reports
• Protecta™ CRT-D D334TRM

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  23 reports
• LATITUDE® Communicator 6280

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  23 reports
• Ilivia Neo 7 VR-T DF-1 ProMRI 429531

  BIOTRONIK SE & Co. KG · Implantable cardioverter defibrillator (non-CRT)
  23 reports
• Consulta® CRT-D D204TRM

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  22 reports
• Lumax 740 VR-T DX 372419

  BIOTRONIK SE & Co. KG · Implantable cardioverter defibrillator (non-CRT)
  22 reports
• Itrevia 7 VR-T DF-1 393040

  BIOTRONIK SE & Co. KG · Implantable cardioverter defibrillator (non-CRT)
  21 reports
• PERCIVA™ ICD VR D400

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

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  17 reports
• Evera™ S DR DDBC3D1

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  16 reports
• ORIGEN™ MINI ICD VR D001

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  16 reports
• Ilesto 7 VR-T DF4 US 383580

  BIOTRONIK SE & Co. KG · Implantable cardioverter defibrillator (non-CRT)
  16 reports
• SPRINT QUATTRO SECURE S™ DXAC/DSP 693575

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  15 reports
• ENDOTAK RELIANCE® SG 0182

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  13 reports
• ORIGEN™ MINI ICD DR D002

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  12 reports
• Durata™ 7171-65

  St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 death12 reports
• Gallant™ CDVRA500T

  St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)
  12 reports
• Protecta™ XT VR D314VRG

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  11 reports
• Lumax 740 VR-T 365609

  BIOTRONIK SE & Co. KG · Implantable cardioverter defibrillator (non-CRT)
  11 reports
• Protecta™ DR D334DRG

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  1 death10 reports
• Protecta™ XT DR D314DRG

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  10 reports
• Sprint Quattro Secure S MRI™ SureScan™ 693565

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  10 reports
• SPRINT QUATTRO SECURE S™ DXAC/DSP 693552

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  9 reports
• NA 6931

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  9 reports
• ENDOTAK RELIANCE® S 0128

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  9 reports
• LATITUDE® Communicator 6476

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  7 reports
• EMBLEM™ S-ICD Electrode Delivery System 4712

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  1 death7 reports
• ORIGEN™ MINI ICD DR D003

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  6 reports
• LATITUDE® Communicator 6290

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  6 reports
• Durata® 7131-65

  St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)
  6 reports
• LATITUDE® Communicator 6498

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  5 reports
• Evera™ S DR DDBC3D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  4 reports
• Rivacor 5 VR-T DF4 ProMRI 429565

  BIOTRONIK SE & Co. KG · Implantable cardioverter defibrillator (non-CRT)
  1 death4 reports
• Durata™ 7121/75

  St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)
  4 reports
• Durata® 7130-60

  St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)
  4 reports
• Evera™ S VR DVBC3D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  3 reports
• Visia AF MRI™ S VR SureScan™ DVFC3D4

  Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
  3 reports
• LATITUDE® Communicator 6280

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  3 reports
• EMBLEM™ S-ICD Programmer 3200

  Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
  3 reports
• Ilesto 5 VR-T DF4 383584

  BIOTRONIK SE & Co. KG · Implantable cardioverter defibrillator (non-CRT)
  3 reports
• Iforia 5 VR-T DX DF-1 383597

  BIOTRONIK SE & Co. KG · Implantable cardioverter defibrillator (non-CRT)
  3 reports
• Rivacor 7 VR-T DX DF4 ProMRI 429535

  BIOTRONIK SE & Co. KG · Implantable cardioverter defibrillator (non-CRT)
  3 reports
• Entrant™ CDVRA300T

  St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)
  3 reports
• Intica Neo 7 VR-T DF-1 ProMRI 429560

  BIOTRONIK SE & Co. KG · Implantable cardioverter defibrillator (non-CRT)
  2 reports
• Rivacor 5 VR-T DX DF4 ProMRI 429564

  BIOTRONIK SE & Co. KG · Implantable cardioverter defibrillator (non-CRT)
  2 reports
• Rivacor 3 VR-T DF4 ProMRI 429574

  BIOTRONIK SE & Co. KG · Implantable cardioverter defibrillator (non-CRT)
  2 reports