FDA Device recall Z-1814-2023
ICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1 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-1814-2023 |
| 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 DVMD3D1 PRIMO MRI, Model Number DVMD3D1; 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 00763000001520, Lot Serial Numbers: CWK604305S, CWK601554S, CWK601693S, CWK601762S, CWK603310S, CWK600674S, CWK60…GTIN 00763000001520, Lot Serial Numbers: CWK604305S, CWK601554S, CWK601693S, CWK601762S, CWK603310S, CWK600674S, CWK605298S, CWK605119S, CWK605216S, CWK605052S, CWK605244S, CWK605024S, CWK605176S, CWK605108S, CWK605326S, CWK605015S, CWK605215S, CWK605100S, CWK605123S, CWK604958S, CWK605229S, CWK605502S, CWK604624S, CWK604625S, CWK604396S, CWK605478S, CWK604413S, CWK604933S, CWK605391S, CWK601948S, CWK601949S, CWK601950S, CWK601953S, CWK601961S, CWK601965S, CWK601966S, CWK601970S, CWK601971S, CWK601972S, CWK601974S, CWK601976S, CWK602568S, CWK602617S, CWK602627S, CWK602632S, CWK602691S, CWK602827S, CWK602843S, CWK602870S, CWK601348S, CWK603369S, CWK604247S, CWK604852S, CWK603773S, CWK601726S, CWK601802S, CWK602031S, CWK602325S, CWK602330S, CWK602332S, CWK602336S, CWK602338S, CWK602339S, CWK602355S, CWK602357S, CWK602577S, CWK602645S, CWK602652S, CWK603257S, CWK603258S, CWK603319S, CWK603334S, CWK603926S, CWK603957S, CWK603969S, CWK604118S, CWK604120S, CWK604127S, CWK604307S, CWK604310S |
|---|
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-1814-2023%22
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