Product Recalls & Refunds Online / National

Medtronic Inc.: Cobalt XT DR MRI SureScan Implantable Cardioverter

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer

Recall reason: 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.. Recalled by Medtronic Inc.. Distribution: US Nationwide distribution in the state of Florida.. Classification (Class II — potential health risk). Affected lots/dates: UDI/DI 00763000178338, Serial Number RSL604096S. Contact the manufacturer or the retailer where you purchased this device to arrange for a free correction, repair, or replacement.

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer
Category Product Recalls & Refunds
Location National
Eligibility U.S. consumers who own or purchased the recalled medical device. Contact the manufacturer or the retailer/pharmacy where you purchased it to arrange for a free correction, repair, or replacement. Have the model number ready if possible.
Source Official Source ↗
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