Medtronic recalls specific model implantable defibrillators due to potential weld cracks causing manufacturing failures. Affected units have unique serial numbers and GTINs. Contact for return or repair options.
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Medtronic is recalling certain COBALT 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 is used, but the risk is not immediate or severe under normal conditions.
People with the specific model number DVPB3D4 implantable defibrillators. Those who have the listed serial numbers or GTINs are most at risk.
Check for the model number DVPB3D4 on the device. Look for the serial numbers RSF612135S, RSF612143S, RSF612097S, or RSF612098S. The GTIN numbers 00763000178512 and 00763000711375 are also associated with these units.
Identify the model number DVPB3D4 and serial numbers listed in the recall notice to confirm if your device is affected.
The recall is due to a potential manufacturing defect that could cause the device to fail during leak checks, but the risk is low under normal use conditions.
Check for the model number DVPB3D4 and the specific serial numbers RSF612135S, RSF612143S, RSF612097S, or RSF612098S, or GTINs 00763000178512 and 00763000711375.
The recall does not specify a remedy, so contact Medtronic directly for further instructions.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2208-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2208-2024 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.
