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Iforia 7 HF-T
BIOTRONIK SE & Co. KG · Model 390060 · UDI-DI 04035479126896
NIK
Prescription
0
510(k) clearances
170,398
Adverse events (4,818 deaths)
153
Recalls
26
Facilities
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 were manufactured p |
| 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) and cardiac resynchr |
| 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) and cardiac resynchr |
| 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) and cardiac resynchr |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.