Medtronic recalls specific MIRRO MRI VR SureScan implantable defibrillators due to potential welding cracks causing manufacturing failures. Affected units have model DVME3D1 and serial numbers listed. No remedy provided in official recall.
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Medtronic is recalling certain MIRRO MRI VR SureScan implantable defibrillators that may have welding cracks causing manufacturing failures. This could lead to device failure during the leak check step, potentially affecting patient safety.
The devices may have a welding crack that causes failure during the leak check step in manufacturing. This defect could lead to the device malfunctioning, potentially affecting patient safety.
Patients with the recalled implantable cardioverter defibrillators are affected. Those with the specific model DVME3D1 and listed serial numbers are most at risk.
Check if your device has model number DVME3D1 and serial numbers CWP605601S, CWP605619S, CWP605620S, CWP605653S, CWP605654S, or CWP605658S.
Verify your device's model number and serial number against the listed numbers to confirm if it's affected.
The recall is due to potential welding cracks that could cause the device to fail during the leak check step in manufacturing.
The official recall notice does not provide a remedy, so you should check with Medtronic directly for guidance.
Yes, the affected serial numbers are CWP605601S, CWP605619S, CWP605620S, CWP605653S, CWP605654S, and CWP605658S.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2204-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2204-2024 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.
