Medtronic Inc. Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
Brand
Medtronic Inc.
Lot Codes / Batch Numbers
UDI/DI 00763000178338, Serial Number RSL604096S
Products Sold
UDI/DI 00763000178338, Serial Number RSL604096S
Medtronic Inc. is recalling Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1 due to During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026