Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
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.
US Nationwide distribution in the state of Florida.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0779-2024