FDA-Device2024-01-31Class II
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
Medtronic Inc.
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.
Sold states
US Nationwide distribution in the state of Florida.
Affected count
1 device
Manufactured in
8200 Coral Sea St Ne, N/A, Mounds View, MN, United States
Products
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0779-2024Don't want to check this manually?
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