Medtronic Inc. recalls Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrill
Recalled Product
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
Hazard / Issue
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.
Issued by
FDA
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