Class II

Medical Device Recall: Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1

Medtronic Inc. · December 7, 2023

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.

States Affected

NATIONWIDE

Quantity Affected

1 device

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0779-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Medtronic Inc. Medical Device Recall: Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1 | SafeCheck