Medtronic recalls MIRRO MRI DR SureScan implantable defibrillators with model DDME3D1 due to potential welding cracks causing manufacturing failures. Affected units have specific serial numbers and GTIN.
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Medtronic is recalling MIRRO MRI DR SureScan implantable defibrillators with model number DDME3D1 because a manufacturing defect may cause welding cracks that fail during leak checks. This could lead to device malfunction if the device is used.
The device may have a welding crack that fails during the leak check step in manufacturing. This defect could cause the device to malfunction if used, potentially leading to health risks.
People with an implanted MIRRO MRI DR SureScan defibrillator model DDME3D1 are affected. Those who have this specific model and are at risk of device malfunction due to the manufacturing defect.
Check for the model number DDME3D1 on the device. Affected units have specific serial numbers: CWS604689S, CWS604691S, CWS604694S, and GTIN 00763000001568.
Look for the model number DDME3D1 and specific serial numbers: CWS604689S, CWS604691S, or CWS604694S.
The recall states a potential manufacturing defect could cause failure during leak checks, but the device may still function safely if the defect is not present.
Check for the model number DDME3D1 and specific serial numbers: CWS604689S, CWS604691S, or CWS604694S.
The recall does not specify a remedy, so contact Medtronic directly for guidance.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2201-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2201-2024 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.
