Home › Device types › NIK
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA product code NIK · Class 3 · Unknown
301
Registered devices
169,567
Adverse events
153
Recalls
0
510(k) clearances
Devices with this code
Amplia MRI™ Quad CRT-D SureScan™ — MEDTRONIC, INC.Unify Quadra™ — ST. JUDE MEDICAL, INC.ORIGEN™ X4 CRT-D — BOSTON SCIENTIFIC CORPORATIONProtecta™ XT CRT-D — MEDTRONIC, INC.SJM™ — ST. JUDE MEDICAL, INC.Allure™ — ST. JUDE MEDICAL, INC.Promote Accel™ — ST. JUDE MEDICAL, INC.Cobalt™ XT HF CRT-D MRI SureScan™ — MEDTRONIC, INC.Claria MRI™ CRT-D SureScan™ — MEDTRONIC, INC.Amplia MRI™ Quad CRT-D SureScan™ — MEDTRONIC, INC.Claria MRI™ Quad CRT-D SureScan™ — MEDTRONIC, INC.Ilesto 5 HF-T — BIOTRONIK SE & Co. KGINOGEN™ X4 CRT-D — BOSTON SCIENTIFIC CORPORATIONEntrant™ — ST. JUDE MEDICAL, INC.Quadra Assura™ — ST. JUDE MEDICAL, INC.Inventra 7 HF-T — BIOTRONIK SE & Co. KGMerlin™ — ST. JUDE MEDICAL, INC.Secura® VR — MEDTRONIC, INC.Viva™ XT CRT-D — MEDTRONIC, INC.Iperia 7 HF-T QP DF4 IS4 — BIOTRONIK SE & Co. KGUnify Assura™ — ST. JUDE MEDICAL, INC.Crome™ HF CRT-D MRI SureScan™ — MEDTRONIC, INC.QUADRA ASSURA MP™ — ST. JUDE MEDICAL, INC.SMARTMAGNET™ — MEDTRONIC, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-04-16 | Medtronic Inc. | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. |
| 2024-04-16 | Medtronic Inc. | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. |
| 2024-04-16 | Medtronic Inc. | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. |
| 2024-04-16 | Medtronic Inc. | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. |
| 2024-04-16 | Medtronic Inc. | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. |
| 2024-04-16 | Medtronic Inc. | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. |
| 2023-08-16 | Abbott Medical | Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchronization Therapy Defibrillator *CRT-D) devices that |
| 2023-05-10 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) |
| 2023-05-10 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) |
| 2023-05-10 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) |
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