Medtronic Inc.: Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1

Hazard

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.

Details from the source

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. Distribution: US Nationwide distribution in the state of Florida. Quantity: 1 device Lot/code info: UDI/DI 00763000178338, Serial Number RSL604096S

UPC codes

00763000178338

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.