CRT-D DTBA1D4 VIVA XT IS1/DF4 US — Class I medical device recall Z-1731-2023
Ongoing recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), reported 2023-06-28, distributed nationwide. There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J)
| Recall number | Z-1731-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN, United States |
| Recall initiated | 2023-05-10 |
| Classified | 2023-06-16 |
| Reported by FDA | 2023-06-28 |
| Distributed | Nationwide (US) |
| Quantity | 661 units |
| UPC / GTIN / UDI-DI | 00643169720251, 00763000059668 |
| Serial numbers | BLE220376H, BLE220377H, BLE220378H, BLE221161H, BLE221162H, BLE221163H, BLE221165H, BLE221166H, BLE221167H, BLE221168H, BLE221172H, BLE221173H, BLE221174H, BLE221176H, BLE221178H, BLE221179H, BLE221180H, BLE221184H, BLE221185H, BLE221188H, BLE221189H, BLE221190H, BLE221191H, BLE221194H, BLE221195H and 475 more |
| Model numbers | DTBA1D4 |
Product
CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4; Implantable Cardioverter Defibrillators
Reason for recall
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 resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1731-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.