Medtronic recalls specific model implantable defibrillators due to potential weld cracks causing manufacturing failures. Affected units have unique 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 CROME VR MRI SureScan implantable defibrillators because a manufacturing defect may cause weld cracks that fail during quality checks. This could lead to device malfunction if the device is used.
The device may have a weld crack that fails during the leak check step in manufacturing. This defect could cause the device to malfunction if it's used.
People with the specific model number DVPC3D1 implantable defibrillators listed in the recall. Those who have the device implanted and are using it are most at risk.
Check for the model number DVPC3D1 on the device. Look for serial numbers starting with RSG601428S through RSG601478S or GTINs 00763000178543 and 00763000711382.
Verify the model number is DVPC3D1 and the serial number matches the list provided in the recall.
The recall is for a potential manufacturing defect that could cause weld cracks, leading to device failure during the leak check step in manufacturing.
Check if your device matches the model and serial numbers listed in the recall. If it does, contact Medtronic for further instructions.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2211-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2211-2024 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.
