Medtronic recalls specific MIRRO MRI VR SureScan defibrillators (model DVME3D4) due to potential weld cracks causing manufacturing failures. Affected units have unique serial numbers listed in the recall notice.
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 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, potentially leading to improper heart rhythm management.
People with an implanted MIRRO MRI VR SureScan defibrillator (model DVME3D4) and the specific serial numbers listed in the recall notice. Those at highest risk are individuals who have received this device as part of their medical treatment.
Check if your defibrillator has the model number DVME3D4 and the serial numbers listed: CWR621520S through CWR621532S. The product was sold with the GTIN 00763000611989.
Look for the serial numbers CWR621520S through CWR621532S on your device label.
Medtronic recalls these specific models due to a potential manufacturing defect that could cause weld cracks, leading to device failure during quality checks.
Check your device's serial number against the list provided in the recall notice. If it matches, contact Medtronic for further instructions.
The recall states a potential manufacturing defect that could cause device failure, but no specific injury risk is mentioned in the official notice.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2205-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2205-2024 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.
