Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator Recalled by Medtronic Inc. Due to During internal review of Polaris battery assembly data...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Inc. directly.
Affected Products
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
Quantity: 1 device
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Inc.
Medtronic Inc. has 85 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report