Medtronic recalls specific models of implantable cardioverter defibrillators due to potential weld cracks causing manufacturing failures. Affected units include model DDPB3D4 with listed serial numbers and GTINs.
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Medtronic is recalling certain implantable cardioverter defibrillators (ICDs) that may have a manufacturing defect causing weld cracks. This defect could lead to devices failing during the leak check step in production, potentially affecting device safety.
The devices may have a weld crack that causes failure during the leak check step in manufacturing. This defect could lead to the device not functioning properly, but the hazard is identified as a manufacturing issue rather than a failure in normal use.
People with implanted Medtronic COBALT DR MRI SureScan defibrillators (model DDPB3D4) that match the listed serial numbers or GTINs are affected. Those who have had the device implanted are most at risk.
Check if your device is model DDPB3D4 with serial numbers listed in the recall notice or GTINs provided. The recall includes specific serial numbers and two GTINs.
Verify your device model and serial numbers against the list provided in the recall notice.
Medtronic recalls these devices due to a potential manufacturing defect that could cause weld cracks, leading to failure during the leak check step in production.
Your device is affected if it is model DDPB3D4 with serial numbers listed in the recall notice or GTINs provided.
Check your device details against the list provided in the recall notice to see if it is affected.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2207-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2207-2024 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.
