Recall Z-0779-2024 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Medtronic Inc.
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
| Date | Jan 22, 2024 (initiated Dec 7, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | Medtronic hand delivered an Urgent Medical Device Recall/Retrieval notice to its sole consignee on 12/07/2023. The notice explained the issue and indicated that the device would be collected and a replacement provided. |
| Quantity | 1 device |
| Distribution | US Nationwide distribution in the state of Florida. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.