ICD-VR VISIA AF S US/OUS IS1/DF1 — Class I medical device recall Z-1793-2023
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-1793-2023 |
|---|---|
| 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 | 176 units |
| UPC / GTIN / UDI-DI | 00643169720770, 00763000052713 |
| Lot numbers | BWU600704S, BWU600705S, BWU600717S, BWU600718S, BWU600719S, BWU600720S, BWU600721S, BWU600722S, BWU600723S, BWU600726S, BWU600727S, BWU600728S, BWU600729S, BWU600730S, BWU600735S, BWU600736S, BWU600767S, BWU600768S, BWU600769S, BWU600770S, BWU600771S, BWU600772S, BWU600774S, BWU600775S, BWU600776S, BWU600777S, BWU600778S, BWU600779S, BWU600782S, BWU600788S, BWU600793S, BWU600795S, BWU600804S, BWU600805S, BWU600806S, BWU600807S, BWU600808S, BWU600809S, BWU600810S, BWU600813S and 68 more |
| Serial numbers | BWU600555S, BWU600556S, BWU600557S, BWU600638S, BWU600639S, BWU600640S, BWU600641S, BWU600642S, BWU600643S, BWU600644S, BWU600645S, BWU600646S, BWU600647S, BWU600648S, BWU600649S, BWU600650S, BWU600651S, BWU600652S, BWU600653S, BWU600654S, BWU600655S, BWU600656S, BWU600658S, BWU600659S, BWU600661S and 43 more |
| Model numbers | DVAC3D1 |
Product
ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; 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-1793-2023. 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.