Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

FDA product code NIK · Class 3 · 195 devices · 62,413 reports · 1,219 deaths reported · 71 devices named in recalls

• Gallant™ CDHFA500Q

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 recalls58 deaths8,401 reports
• Quartet™ 1458Q-86

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  207 deaths6,631 reports
• QUADRA ASSURA MP™ CD3369-40Q

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  103 deaths6,084 reports
• VIGILANT™ X4 CRT-D G247

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  17 deaths2,066 reports
• Quadra Assura™ CD3365-40Q

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  53 deaths2,056 reports
• Cobalt™ XT HF Quad CRT-D MRI SureScan™ DTPA2QQ

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 recalls40 deaths1,639 reports
• Unify Assura™ CD3357-40Q

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  54 deaths1,784 reports
• Unify Assura™ CD3357-40C

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  56 deaths1,588 reports
• Claria MRI™ Quad CRT-D SureScan™ DTMA1QQ

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  22 deaths1,479 reports
• Quartet™ 1456Q/86

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  25 deaths1,372 reports
• Claria MRI™ Quad CRT-D SureScan™ DTMA1QQ

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall35 deaths1,243 reports
• INOGEN™ X4 CRT-D G148

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  8 deaths1,252 reports
• RESONATE™ X4 CRT-D G447

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  13 deaths1,218 reports
• DYNAGEN™ X4 CRT-D G158

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  13 deaths1,166 reports
• Cobalt™ HF Quad CRT-D MRI SureScan™ DTPB2QQ

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 recalls19 deaths868 reports
• QUADRA ASSURA MP™ CD3369-40C

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  31 deaths910 reports
• Quartet™ 1458QL/86

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  25 deaths896 reports
• Amplia MRI™ Quad CRT-D SureScan™ DTMB1QQ

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 recalls18 deaths648 reports
• MOMENTUM™ CRT-D G125

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 deaths792 reports
• MOMENTUM™ CRT-D G124

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  5 deaths790 reports
• EASYTRAK® 2 IS-1 4543

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  5 deaths727 reports
• Viva™ Quad XT CRT-D DTBA1QQ

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 recalls19 deaths620 reports
• Cobalt™ XT HF CRT-D MRI SureScan™ DTPA2D4

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 recalls12 deaths452 reports
• Quartet™ 1458Q-75

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  23 deaths545 reports
• RESONATE™ HF CRT-D G547

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death542 reports
• EASYTRAK® 2 IS-1 4542

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 deaths536 reports
• DYNAGEN™ CRT-D G151

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 deaths533 reports
• MOMENTUM™ X4 CRT-D G138

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 deaths507 reports
• Viva™ XT CRT-D DTBA1D4

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 recalls7 deaths374 reports
• Claria MRI™ CRT-D SureScan™ DTMA1D1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall7 deaths415 reports
• Allure™ PM3222

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  8 deaths463 reports
• Claria MRI™ CRT-D SureScan™ DTMA1D4

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall7 deaths409 reports
• Cobalt™ XT HF CRT-D MRI SureScan™ DTPA2D1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 recalls8 deaths249 reports
• Viva™ XT CRT-D DTBA1D1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 recalls8 deaths333 reports
• Merlin™ 3650

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall1 death380 reports
• INOGEN™ CRT-D G141

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death415 reports
• DYNAGEN™ CRT-D G150

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 deaths410 reports
• Cobalt™ XT HF Quad CRT-D MRI SureScan™ DTPA2Q1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 recalls7 deaths194 reports
• Allure Quadra™ PM3242

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  18 deaths391 reports
• Entrant™ CDHFA300Q

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall3 deaths341 reports
• Cobalt™ HF CRT-D MRI SureScan™ DTPB2D4

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 recalls5 deaths179 reports
• DYNAGEN™ X4 CRT-D G156

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  7 deaths379 reports
• Quadra Assura™ CD3265-40Q

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  12 deaths359 reports
• Claria MRI™ CRT-D SureScan™ DTMA1D4

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

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall7 deaths289 reports
• Cobalt™ HF CRT-D MRI SureScan™ DTPB2D1

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

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 recalls8 deaths227 reports
• Claria MRI™ CRT-D SureScan™ DTMA1D1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall10 deaths269 reports
• Amplia MRI™ Quad CRT-D SureScan™ DTMB1QQ

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall5 deaths268 reports
• Claria MRI™ Quad CRT-D SureScan™ DTMA1QQ

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 recalls4 deaths116 reports
• Quartet™ 1458Q

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  15 deaths314 reports
• Quadra Assura™ CD3365-40C

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  9 deaths313 reports
• Merlin™ 3330

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  6 recalls0 reports
• Cobalt™ HF Quad CRT-D MRI SureScan™ DTPB2Q1

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

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 recalls1 death76 reports
• Amplia MRI™ CRT-D SureScan™ DTMB1D4

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls4 deaths122 reports
• Claria MRI™ Quad CRT-D SureScan™ DTMA1Q1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall6 deaths213 reports
• Rivacor 7 HF-T QP DF4 IS4 ProMRI 429532

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  5 deaths255 reports
• Viva™ Quad XT CRT-D DTBA1QQ

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 recalls2 deaths146 reports
• Claria MRI™ Quad CRT-D SureScan™ DTMA1QQ

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall5 deaths194 reports
• Amplia MRI™ CRT-D SureScan™ DTMB1D1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls1 death85 reports
• Amplia MRI™ Quad CRT-D SureScan™ DTMB1QQ

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall2 deaths177 reports
• Amplia MRI™ Quad CRT-D SureScan™ DTMB1Q1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls2 deaths68 reports
• Claria MRI™ CRT-D SureScan™ DTMA1D1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls63 reports
• Compia MRI™ Quad CRT-D SureScan™ DTMC1QQ

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls2 deaths59 reports
• Claria MRI™ Quad CRT-D SureScan™ DTMA1Q1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls51 reports
• INOGEN™ X4 CRT-D G146

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  6 deaths201 reports
• Secura® DR D224DRG

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death194 reports
• Protecta™ XT CRT-D D314TRG

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  6 deaths185 reports
• Claria MRI™ CRT-D SureScan™ DTMA1D4

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls33 reports
• EASYTRAK® 2 4518

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death180 reports
• Crome™ HF CRT-D MRI SureScan™ DTPC2D4

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls1 death28 reports
• Viva™ S CRT-D DTBB1D4

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 recalls64 reports
• Amplia MRI™ CRT-D SureScan™ DTMB1D1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall3 deaths114 reports
• Crome™ HF CRT-D MRI SureScan™ DTPC2D1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls13 reports
• Crome™ HF Quad CRT-D MRI SureScan™ DTPC2Q1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls9 reports
• Viva™ XT CRT-D DTBA1D4

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 recalls1 death58 reports
• Amplia MRI™ Quad CRT-D SureScan™ DTMB1QQ

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall3 deaths107 reports
• Protecta™ XT DR D314DRM

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  8 deaths155 reports
• Viva™ Quad S CRT-D DTBB1QQ

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall3 deaths101 reports
• DYNAGEN™ CRT-D G154

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death150 reports
• UNIFY™ CD3231-40

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  8 deaths148 reports
• Acticor 7 HF-T QP DF4 IS4 ProMRI 429522

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death144 reports
• Viva™ Quad S CRT-D DTBB1Q1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 recalls1 death43 reports
• INOGEN™ CRT-D G140

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 deaths134 reports
• Unify Quadra™ CD3249-40Q

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  7 deaths134 reports
• Ilivia 7 HF-T QP DF4 IS4 ProMRI 404621

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 deaths133 reports
• Amplia MRI™ CRT-D SureScan™ DTMB1D1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall1 death82 reports
• Amplia MRI™ CRT-D SureScan™ DTMB1D4

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall4 deaths82 reports
• Gallant™ CDHFA500D

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death131 reports
• Amplia MRI™ Quad CRT-D SureScan™ DTMB1Q1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall1 death78 reports
• Viva™ Quad XT CRT-D DTBA1Q1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall2 deaths77 reports
• Viva™ XT CRT-D DTBA1D1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall2 deaths75 reports
• Amplia MRI™ CRT-D SureScan™ DTMB1D4

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall1 death75 reports
• Compia MRI™ Quad CRT-D SureScan™ DTMC1QQ

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall4 deaths69 reports
• Viva™ S CRT-D DTBB1D1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall3 deaths67 reports
• Viva™ XT CRT-D DTBA1D1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall1 death65 reports
• Claria MRI™ CRT-D SureScan™ DTMA1D1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall65 reports
• MOMENTUM™ CRT-D G126

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  115 reports
• Compia MRI™ CRT-D SureScan™ DTMC1D1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 recalls11 reports