Medtronic recalls specific implantable cardioverter defibrillators with potential manufacturing defects that could cause device failure during leak checks.
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Medtronic is recalling certain implantable cardioverter defibrillators that may have a manufacturing defect causing them to fail during leak checks. This could lead to device malfunction if the device is implanted.
The devices may have a weld crack that causes them to fail during the leak check step in manufacturing. This defect could lead to device malfunction if the device is implanted.
People who own or use the recalled implantable cardioverter defibrillators. Those with implanted devices are most at risk if the device fails.
Check for the model names and serial numbers listed in the recall notice. The devices include VIVA QUAD XT CRT-D, CLARIA MRI CRT-D SureScan, and other specific models with matching GTIN and serial numbers.
Identify if your device matches the listed models and serial numbers in the recall notice.
The recall states there is a potential manufacturing defect that could cause device failure during leak checks, but the devices are not unsafe to use if they are not defective.
Check the model and serial numbers against the list provided in the recall notice to see if your device is affected.
The recall notice does not specify a replacement process or remedy for affected devices.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2212-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2212-2024 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.
