ICD-VR DVBB2D4 EVERA XT DF4 INTL — Class I medical device recall Z-1798-2023
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-1798-2023 |
|---|---|
| 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 | 447 units |
| UPC / GTIN / UDI-DI | 00643169218024, 00643169969575, 00643169980259, 00763000612122 |
| Serial numbers | BWJ606950S, BWJ606951S, BWJ606991S, BWJ606992S, BWJ606993S, BWJ606994S, BWJ606995S, BWJ606996S, BWJ606997S, BWJ606998S, BWJ607002S, BWJ607003S, BWJ607005S, BWJ607006S, BWJ607007S, BWJ607008S, BWJ607010S, BWJ607011S, BWJ607012S, BWJ607013S, BWJ607015S, BWJ607016S, BWJ607019S, BWJ607020S, BWJ607022S and 422 more |
| Model numbers | DVBB2D4 |
Product
ICD-VR DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4; 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-1798-2023. 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.