FDA Device recall Z-0779-2024
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
- FDA Device
- Class II
- ongoing
- Published 2024-01-31
On 2024-01-31 the FDA classified a Class II recall of Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1 by Medtronic, citing during internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twic….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0779-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-07 |
| Published | 2024-01-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic |
| Distribution | US |
Product
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
Reason
During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the test screen did not prevent retesting after a failure. Some batteries were therefore retested and passed.
Identifiers
| code_info | UDI/DI 00763000178338, Serial Number RSL604096S |
|---|
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-0779-2024%22
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