FDA Device recall Z-2198-2024
EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator
- FDA Device
- Class II
- ongoing
- Published 2024-07-03
On 2024-07-03 the FDA classified a Class II recall of EVERA MRI S DR SureScan, Model Number DDMC3D1, 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-2198-2024 |
| 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
EVERA MRI S DR SureScan, Model Number DDMC3D1, 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: 00763000206192, Serial Number: CWC613698S, CWC613700S, CWC613713S, CWC613715S, CWC613717S. |
|---|
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-2198-2024%22
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