FDA Device recall Z-1793-2023
ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1 by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing 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 resynch….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1793-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-05-10 |
| Published | 2023-06-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | US |
Product
ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; Implantable Cardioverter Defibrillators
Reason
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.
Identifiers
| code_info | GTIN 00643169720770, Lot Serial numbers: BWU600672S, BWU600685S, BWU600654S, BWU600656S, BWU600555S, BWU600638S, BWU60…GTIN 00643169720770, Lot Serial numbers: BWU600672S, BWU600685S, BWU600654S, BWU600656S, BWU600555S, BWU600638S, BWU600641S, BWU600642S, BWU600647S, BWU600648S, BWU600650S, BWU600651S, BWU600664S, BWU600643S, BWU600645S, BWU600557S, BWU600556S, BWU600763S, BWU600640S, BWU600639S, BWU600649S, BWU600661S, BWU600662S, BWU600663S, BWU600665S, BWU600666S, BWU600671S, BWU600673S, BWU600676S, BWU600646S, BWU600652S, BWU600653S, BWU600655S, BWU600658S, BWU600659S, BWU600667S, BWU600668S, BWU600669S, BWU600684S, BWU600694S, BWU600695S, BWU600696S, BWU600697S, BWU600698S, BWU600699S, BWU600700S, BWU600701S, BWU600702S, BWU600703S, BWU600707S, BWU600708S, BWU600709S, BWU600710S, BWU600711S, BWU600714S, BWU600715S, BWU600716S, BWU600739S, BWU600741S, BWU600758S, BWU600760S, BWU600761S, BWU600762S, BWU600764S, BWU600765S, BWU600766S, BWU600712S, BWU600644S; GTIN 00763000052713, Lot Numbers: BWU600776S, BWU600721S, BWU600810S, BWU600771S, BWU600772S, BWU600774S, BWU600723S, BWU600795S, BWU600820S |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1793-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.