FDA Device recall Z-1791-2023
ICD-VR VISIA AF XT OUS IS1/DF1, Model Number DVAB2D1
- 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 XT OUS IS1/DF1, Model Number DVAB2D1 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-1791-2023 |
| 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 XT OUS IS1/DF1, Model Number DVAB2D1; 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 00643169720756, Lot Serial Numbers: BWR600821S, BWR600947S, BWR600936S, BWR600937S, BWR600941S, BWR600946S, BWR60…GTIN 00643169720756, Lot Serial Numbers: BWR600821S, BWR600947S, BWR600936S, BWR600937S, BWR600941S, BWR600946S, BWR600959S, BWR601046S, BWR600938S, BWR601096S, BWR601093S, BWR600979S, BWR601092S, BWR600997S, BWR600934S, BWR600965S, BWR601050S, BWR601049S, BWR600823S, BWR601053S, BWR600983S, BWR600989S, BWR600984S, BWR601055S, BWR601057S, BWR601098S, BWR600822S, BWR600980S, BWR600981S, BWR600982S, BWR601097S, BWR601100S, BWR601095S, BWR601101S, BWR600991S, BWR601051S, BWR601058S, BWR601099S, BWR601094S; GTIN BWR601149S, BWR601155S, BWR601137S, BWR601138S, BWR601108S, BWR601113S, BWR601111S, BWR601119S, BWR601144S, BWR601146S, BWR601147S, BWR601148S, BWR601067S, BWR601150S, BWR601152S, BWR601115S, BWR601105S, BWR601112S, BWR601059S, BWR601061S, BWR601062S, BWR601063S, BWR601072S, BWR601073S, BWR601078S, BWR601081S, BWR601090S, BWR601116S, BWR601103S, BWR601075S, BWR601102S, BWR601104S |
|---|
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-1791-2023%22
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