CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL — Class I medical device recall Z-1752-2023
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-1752-2023 |
|---|---|
| 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 | 7,994 units |
| UPC / GTIN / UDI-DI | 00643169720183, 00643169980167, 00763000612344 |
| Serial numbers | BLX609800S, BLX609802S, BLX610254S, BLX610255S, BLX610257S, BLX610258S, BLX610259S, BLX610260S, BLX610261S, BLX610262S, BLX610263S, BLX610264S, BLX610265S, BLX610266S, BLX610267S, BLX610268S, BLX610269S, BLX610270S, BLX610271S, BLX610272S, BLX610273S, BLX610274S, BLX610275S, BLX610276S, BLX610277S and 475 more |
| Model numbers | DTBC2QQ |
Product
CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; 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-1752-2023. 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.