FDA Device recall Z-1815-2023
ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4 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-1815-2023 |
| 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 DVMD3D4 PRIMO MRI, Model Number DVMD3D4; 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 00763000001544, Lot Serial Numbers: CWL609971S, CWL607669S, CWL607665S, CWL601100S, CWL608311S, CWL608330S, CWL60…GTIN 00763000001544, Lot Serial Numbers: CWL609971S, CWL607669S, CWL607665S, CWL601100S, CWL608311S, CWL608330S, CWL606893S, CWL611845S, CWL613316S, CWL613041S, CWL613322S, CWL613037S, CWL612708S, CWL610673S, CWL613504S, CWL613431S, CWL610444S, CWL611258S, CWL612781S, CWL611134S, CWL612934S, CWL610677S, CWL610760S, CWL611725S, CWL612705S, CWL612392S, CWL612791S, CWL613155S, CWL608262S, CWL613137S, CWL613177S, CWL613296S, CWL613214S, CWL613134S, CWL610869S, CWL612023S, CWL605532S, CWL604332S, CWL604336S, CWL604346S, CWL604350S, CWL604352S, CWL604353S, CWL604357S, CWL604361S, CWL604363S, CWL604365S, CWL604367S, CWL604368S, CWL605564S, CWL605583S, CWL605779S, CWL607583S, CWL607825S, CWL608913S, CWL608914S, CWL608966S, CWL609174S, CWL601407S, CWL602224S, CWL604372S, CWL604374S, CWL607414S, CWL607688S, CWL609146S, CWL609294S, CWL610670S, CWL604082S, CWL604249S, CWL604273S, CWL604611S, CWL605101S, CWL605102S, CWL605103S, CWL605105S, CWL605106S, CWL605233S, CWL605235S, CWL605632S, CWL605645S |
|---|
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-1815-2023%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.