Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

FDA product code NKE · Class 3 · 34 devices · 9,665 reports · 157 deaths reported · 9 devices named in recalls

• VALITUDE™ X4 CRT-P U128

  Boston Scientific Corporation · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  2 recalls26 deaths2,073 reports
• Quadra Allure MP™ PM3562

  St. Jude Medical, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  26 deaths1,180 reports
• Percepta™ Quad CRT-P MRI SureScan™ W4TR01

  Medtronic, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  1 recall28 deaths897 reports
• VISIONIST™ X4 CRT-P U228

  Boston Scientific Corporation · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  1 recall4 deaths819 reports
• Percepta™ Quad CRT-P MRI SureScan™ W4TR01

  Medtronic, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  1 recall8 deaths703 reports
• INVIVE™ V173

  Boston Scientific Corporation · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  1 death670 reports
• VALITUDE™ CRT-P U125

  Boston Scientific Corporation · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  2 recalls2 deaths558 reports
• QUADRA ALLURE MP™ PM3262

  St. Jude Medical, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  27 deaths518 reports
• Percepta™ CRT-P MRI SureScan™ W1TR01

  Medtronic, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  1 recall4 deaths300 reports
• VISIONIST™ CRT-P U225

  Boston Scientific Corporation · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  1 recall2 deaths253 reports
• Percepta™ CRT-P MRI SureScan™ W1TR01

  Medtronic, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  1 recall2 deaths218 reports
• INTUA™ V273

  Boston Scientific Corporation · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  264 reports
• Viva™ CRT-P C6TR01

  Medtronic, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  1 death151 reports
• Solara™ Quad CRT-P MRI SureScan™ W4TR03

  Medtronic, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  2 deaths140 reports
• Serena™ Quad CRT-P MRI SureScan™ W4TR02

  Medtronic, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  3 deaths118 reports
• VISIONIST™ CRT-P U226

  Boston Scientific Corporation · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  2 recalls18 reports
• Solara™ Quad CRT-P MRI SureScan™ W4TR03

  Medtronic, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  5 deaths102 reports
• Edora 8 HF-T QP 407137

  BIOTRONIK SE & Co. KG · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  1 death98 reports
• Serena™ Quad CRT-P MRI SureScan™ W4TR02

  Medtronic, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  1 death90 reports
• Solara™ CRT-P MRI SureScan™ W1TR03

  Medtronic, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  3 deaths76 reports
• ANTHEM™ PM3210

  St. Jude Medical, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  5 deaths61 reports
• Serena™ CRT-P MRI SureScan™ W1TR02

  Medtronic, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  2 deaths59 reports
• Serena™ CRT-P MRI SureScan™ W1TR02

  Medtronic, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  52 reports
• Syncra™ CRT-P C2TR01

  Medtronic, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  1 death51 reports
• Solara™ CRT-P MRI SureScan™ W1TR03

  Medtronic, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  1 death50 reports
• Quadra Allure™ PM3542

  St. Jude Medical, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  46 reports
• INTUA™ V272

  Boston Scientific Corporation · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  23 reports
• Edora 8 HF-T 407138

  BIOTRONIK SE & Co. KG · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  22 reports
• Etrinsa 8 HF-T 394919

  BIOTRONIK SE & Co. KG · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  1 death20 reports
• INVIVE™ V172

  Boston Scientific Corporation · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  10 reports
• Amvia Edge HF-T QP 460162

  BIOTRONIK SE & Co. KG · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  10 reports
• Evia HF-T 377208

  BIOTRONIK SE & Co. KG · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  1 death8 reports
• Frontier™ II

  St. Jude Medical, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  4 reports
• QUADRA ALLURE MP™ PM3160

  St. Jude Medical, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  3 reports