Class II — BIOTRONIK Inc
| Recalling firm | BIOTRONIK, INC. |
|---|---|
| Registered facility | BIOTRONIK, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Product | BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI, REF 429559, UDI: 04035479156855 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias. |
| Quantity | 17 UNITS |
| Distribution | US: Nationwide OUS: Worldwide |
| Initiated | 2021-03-08 |
| Classified | 2021-04-21 |
| Terminated | 2023-04-25 |
| Recall number | Z-1463-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — BIOTRONIK Inc (Z-1463-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87549/
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