CRT-D DTBC2D4 BRAVA IS1/DF4 INTL — Class I medical device recall Z-1750-2023
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-1750-2023 |
|---|---|
| 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 | 3,355 units |
| UPC / GTIN / UDI-DI | 00643169720305, 00643169980136, 00763000612320 |
| Serial numbers | BLZ603421S, BLZ603422S, BLZ603573S, BLZ603574S, BLZ603575S, BLZ603576S, BLZ603577S, BLZ603580S, BLZ603582S, BLZ603583S, BLZ603584S, BLZ603585S, BLZ603586S, BLZ603587S, BLZ603588S, BLZ603589S, BLZ603590S, BLZ603593S, BLZ603594S, BLZ603595S, BLZ603596S, BLZ603597S, BLZ603598S, BLZ603599S, BLZ603602S and 475 more |
| Model numbers | DTBC2D4 |
Product
CRT-D DTBC2D4 BRAVA IS1/DF4 INTL, Model Number DTBC2D4; 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-1750-2023. 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.