Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
This recall is currently active, issued January 22, 2024. It was issued by Medtronic Inc..
- Company
- Medtronic Inc.
- Recall Initiated
- December 7, 2023
- Posted
- January 22, 2024
- Recall Number
- Z-0779-2024
- Quantity
- 1 device
- Firm Location
- Mounds View, MN
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution in the state of Florida.
Lot / Code Info
UDI/DI 00763000178338, Serial Number RSL604096S
Root Cause
Nonconforming Material/Component
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.