FDA Recall
Open, Classified
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
Recall: Z-0779-2024
·
Initiated December 7, 2023
Recall
- Recall Number
- Z-0779-2024
- Event Number
- 93663
- Firm
- Medtronic Inc.
- FEI Number
- 2182208
- Product Code
- LWS
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- December 7, 2023
- Posted
- January 22, 2024
- Address
- 8200 Coral Sea St Ne, Mounds View, MN, 55112-4391
Description
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.
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.
Distribution
US Nationwide distribution in the state of Florida.
Quantity
1 device