Recall Z-0779-2024— Medtronic Inc.
Class II · Ongoing
Class II FDA medical device recall by Medtronic Inc., initiated 2023-12-07. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Medtronic Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-12-07
- Firm location
- Mounds View, MN, United States
Product description
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.