Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
FDA device recall Z-0779-2024 · posted 2024-01-22 · Open, Classified
Recall details
- Recalling firm
- Medtronic Inc.
- Reason for recall
- 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 taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- LWS
- Quantity affected
- 1 device
- Distribution
- US Nationwide distribution in the state of Florida.
- Date initiated
- 2023-12-07
- Date posted
- 2024-01-22
- Location
- Mounds View, MN
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