CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL — Class I medical device recall Z-1735-2023
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-1735-2023 |
|---|---|
| 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 | 4,354 units |
| UPC / GTIN / UDI-DI | 00643169217959, 00643169720343, 00643169980082, 00763000612238 |
| Serial numbers | BLJ620814S, BLJ620815S, BLJ621356S, BLJ621357S, BLJ621359S, BLJ621360S, BLJ621361S, BLJ621362S, BLJ621363S, BLJ621364S, BLJ621365S, BLJ621366S, BLJ621367S, BLJ621368S, BLJ621369S, BLJ621370S, BLJ621371S, BLJ621372S, BLJ621373S, BLJ621375S, BLJ621376S, BLJ621377S, BLJ621378S, BLJ621379S, BLJ621380S and 475 more |
| Model numbers | DTBA2D1 |
Product
CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1; 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-1735-2023. 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.