medical Class II Updated 2024-01-31

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

Distribution: Nationwide (United States)
Lot/Code Info: UDI/DI 00763000178338, Serial Number RSL604096S
View official government recall

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