Medtronic recalls specific MIRRO MRI DR SureScan implantable defibrillators due to potential welding cracks causing manufacturing failures. Affected units have unique serial numbers and GTINs.
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Medtronic is recalling certain MIRRO MRI DR SureScan implantable defibrillators because a manufacturing defect may cause welding cracks that fail during quality 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 it's used.
People with an implanted MIRRO MRI DR SureScan defibrillator (model DDME3D4) that has one of the listed serial numbers or GTINs are affected. Those who have the device implanted are most at risk.
Check if your device has the model number DDME3D4 and one of the listed serial numbers or GTINs. The device is an implantable cardioverter defibrillator used for heart conditions.
Identify if your device has the model number DDME3D4 and one of the listed serial numbers or GTINs.
The recall is due to a potential manufacturing defect that could cause welding cracks, leading to device failure during the leak check step in manufacturing.
Check if your device has the model number DDME3D4 and one of the listed serial numbers or GTINs. If it does, contact Medtronic for further instructions.
The recall states a potential manufacturing defect could cause device failure, but it does not specify a risk of serious injury in normal use.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2202-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2202-2024 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.
