FDA Device recall Z-1810-2023
ICD-VR DVMB2D1 EVERA MRI XT OUS DF1, Model Number DVMB2D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-VR DVMB2D1 EVERA MRI XT OUS DF1, Model Number DVMB2D1 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-1810-2023 |
| 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 DVMB2D1 EVERA MRI XT OUS DF1, Model Number DVMB2D1; 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 00643169837768, Lot Serial Numbers: CWE602084S, CWE601758S, CWE600712S, CWE602003S, CWE600626S, CWE600766S, CWE60…GTIN 00643169837768, Lot Serial Numbers: CWE602084S, CWE601758S, CWE600712S, CWE602003S, CWE600626S, CWE600766S, CWE601482S, CWE601602S, CWE602520S, CWE602570S, CWE602622S, CWE601590S, CWE602288S, CWE601918S, CWE602150S, CWE602184S, CWE602565S, CWE602589S, CWE600926S, CWE600588S, CWE601390S, CWE601395S, CWE601481S, CWE601541S, CWE601612S, CWE601749S, CWE601831S, CWE601843S, CWE602038S, CWE600874S, CWE601632S, CWE601996S, CWE602041S, CWE601792S, CWE602396S, CWE600375S, CWE601990S, CWE600553S, CWE601369S, CWE601392S, CWE601766S, CWE601769S, CWE601695S, CWE601401S, CWE601470S, CWE602016S, CWE602094S, CWE602195S, CWE602495S, CWE600746S, CWE601256S, CWE600733S, CWE601348S, CWE601487S, CWE601524S, CWE600350S, CWE600974S, CWE601438S, CWE601700S, CWE601989S, CWE602012S, CWE602376S, CWE600461S, CWE600373S, CWE600530S, CWE601325S, CWE601582S, CWE601644S, CWE601701S, CWE601995S, CWE601282S, CWE601850S, CWE601890S, CWE600526S, CWE602605S, CWE600525S, CWE600372S, CWE600396S, CWE601006S, CWE601277S |
|---|
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-1810-2023%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.