FDA Device recall Z-1794-2023
ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4
- 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 DF4, Model Number DVAC3D4 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-1794-2023 |
| 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 DF4, Model Number DVAC3D4; 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 00643169720787, Lot Serial Numbers: BWV600051S, BWV600052S, BWV600078S, BWV600079S, BWV600010S, BWV600094S, BWV60…GTIN 00643169720787, Lot Serial Numbers: BWV600051S, BWV600052S, BWV600078S, BWV600079S, BWV600010S, BWV600094S, BWV600024S, BWV600027S, BWV600031S, BWV600032S, BWV600041S, BWV600042S, BWV600043S, BWV600044S, BWV600045S, BWV600046S, BWV600047S, BWV600068S, BWV600069S, BWV600070S, BWV600071S, BWV600072S, BWV600073S, BWV600074S, BWV600087S, BWV600088S, BWV600089S, BWV600090S, BWV600099S, BWV600101S, BWV600105S, BWV600107S, BWV600108S, BWV600109S, BWV600110S, BWV600111S, BWV600112S, BWV600113S, BWV600114S, BWV600115S, BWV600155S, BWV600157S, BWV600160S, BWV600161S, BWV600162S, BWV600163S, BWV600164S, BWV600165S, BWV600166S, BWV600167S, BWV600168S, BWV600170S, BWV600171S, BWV600172S, BWV600173S, BWV600174S, BWV600175S, BWV600176S, BWV600177S, BWV600178S, BWV600179S, BWV600180S, BWV600181S, BWV600183S, BWV600184S, BWV600185S, BWV600186S, BWV600187S, BWV600022S, BWV600025S, BWV600026S, BWV600028S, BWV600029S, BWV600030S, BWV600033S, BWV600034S, BWV600035S, BWV600036S, BWV600037S, BWV600038S |
|---|
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-1794-2023%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.