Medtronic recalls Cobalt XT DR MRI SureScan defibrillators with product number DDPA2D1 due to potential battery retesting during quality checks, which may affect safety.
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.
Medtronic is recalling a specific model of implantable defibrillator because batteries were retested after failing quality checks. This could lead to battery issues that might affect device safety.
During quality testing, some batteries were retested after failing the High Potential test. This could mean the batteries were not properly checked for safety, potentially leading to battery issues.
People with the Cobalt XT DR MRI SureScan defibrillator (product number DDPA2D1) are affected. Those with the specific serial number RSL604096S are at higher risk.
Check for product number DDPA2D1 on the device label. The specific serial number RSL604096S indicates the recalled units.
Look for product number DDPA2D1 and serial number RSL604096S on the device.
The recall is due to potential battery retesting during quality checks, but the device itself is not considered dangerous. Medtronic states this is a low-risk issue.
Check for product number DDPA2D1 and serial number RSL604096S on the device label.
The recall does not require immediate action. Check the device label for the product number and serial number to confirm if it's affected.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0779-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0779-2024 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
