CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL — Class I medical device recall Z-1738-2023
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-1738-2023 |
|---|---|
| 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 | 1,132 units |
| UPC / GTIN / UDI-DI | 00643169400603, 00643169720220, 00643169980174 |
| Serial numbers | BLH604699S, BLH604700S, BLH604721S, BLH604833S, BLH604835S, BLH604836S, BLH604837S, BLH604838S, BLH604839S, BLH604840S, BLH604842S, BLH604843S, BLH604844S, BLH604845S, BLH604849S, BLH604852S, BLH604853S, BLH604854S, BLH604857S, BLH604858S, BLH604859S, BLH604860S, BLH604861S, BLH604862S, BLH604865S and 475 more |
| Model numbers | DTBA2Q1 |
Product
CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1; 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-1738-2023. 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.