ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1 — Class I medical device recall Z-1805-2023
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-1805-2023 |
|---|---|
| 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 | 4,546 units |
| UPC / GTIN / UDI-DI | 00643169837805, 00643169859296, 00763000206345 |
| Serial numbers | CWH600820S, CWH600935S, CWH600942S, CWH600944S, CWH600946S, CWH600948S, CWH600949S, CWH600950S, CWH600952S, CWH600954S, CWH600957S, CWH600958S, CWH600959S, CWH600960S, CWH600963S, CWH600964S, CWH600965S, CWH600966S, CWH600967S, CWH600968S, CWH600969S, CWH600970S, CWH600971S, CWH600972S, CWH600973S and 475 more |
| Model numbers | DVFB2D1 |
Product
ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; 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-1805-2023. 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.