FDA Device recall Z-1799-2023
ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1 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-1799-2023 |
| 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 DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; 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 00643169720473, Lot Serial Numbers: BWM204909H, BWM204998H, BWM205011H, BWM205017H, BWM204963H, BWM204962H, BWM2…GTIN 00643169720473, Lot Serial Numbers: BWM204909H, BWM204998H, BWM205011H, BWM205017H, BWM204963H, BWM204962H, BWM205000H, BWM204927H, BWM204911H, BWM204921H, BWM204926H, BWM204932H, BWM204936H, BWM204944H, BWM204954H, BWM204955H, BWM204959H, BWM204983H, BWM204984H, BWM204989H, BWM204990H, BWM205004H, BWM205006H, BWM205008H, BWM205013H, BWM205014H, BWM205015H, BWM205016H, BWM205019H, BWM205021H, BWM205023H, BWM205024H, BWM205027H, BWM205033H, BWM205036H, BWM205037H, BWM204792H, BWM204938H, BWM204961H, BWM204916H, BWM204922H, BWM204950H, BWM204957H, BWM204993H, BWM205009H, BWM204923H, BWM204924H, BWM204987H, BWM205028H, BWM204956H, BWM204953H, BWM204789H, BWM204790H, BWM204935H, BWM204905H, BWM204906H, BWM204960H, BWM204980H, BWM204991H, BWM204914H, BWM204933H, BWM204985H, BWM204997H, BWM204948H, BWM204971H, BWM204992H, BWM205007H, BWM205034H, BWM204793H, BWM204904H, BWM204910H, BWM204970H, BWM204977H, BWM204982H, BWM204928H, BWM204930H, BWM205002H, BWM205035H, BWM204967H, BWM204974 |
|---|
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-1799-2023%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.