Cobalt XT DR MRI SureScan Implantable Cardioverter recall
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
Why was Cobalt XT DR MRI SureScan Implantable Cardioverter recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 00763000178338, Serial Number RSL604096S
- Product
- Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
- Recalling firm
- Medtronic Inc.
- Quantity
- 1 device
- Distribution
- US Nationwide distribution in the state of Florida.
- Recall date
- January 31, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)