FDA Device recall Z-2205-2024
MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
- FDA Device
- Class II
- ongoing
- Published 2024-07-03
On 2024-07-03 the FDA classified a Class II recall of MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator by Medtronic, citing potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2205-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-16 |
| Published | 2024-07-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic |
| Distribution | US |
Product
MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
Reason
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Identifiers
| code_info | GTIN: 00763000611989, Serial Numbers: CWR621520S, CWR621521S, CWR621522S, CWR621523S, CWR621524S, CWR621525S, CWR621526…GTIN: 00763000611989, Serial Numbers: CWR621520S, CWR621521S, CWR621522S, CWR621523S, CWR621524S, CWR621525S, CWR621526S, CWR621527S, CWR621528S, CWR621529S, CWR621530S, CWR621531S, CWR621532S. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2205-2024%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.