Medtronic recalls specific model implantable defibrillators due to potential weld 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 EVERA MRI S DR SureScan implantable defibrillators that may have a manufacturing defect causing weld cracks. This could lead to device failure during the leak check process, potentially putting users at risk.
The devices may have a weld crack that causes failure during the leak check step in manufacturing. This defect could lead to the device not functioning properly, but the hazard is not described as causing immediate injury or serious harm in normal use.
People with the recalled implantable defibrillators (model DDMC3D4) are affected. Those who have the specific serial numbers or GTINs listed are most at risk.
Check if your defibrillator has the model number DDMC3D4 and one of the listed serial numbers or GTINs. The specific serial numbers and GTINs are provided in the recall notice.
Verify your defibrillator's model number and serial number against the list of affected units provided in the recall notice.
Medtronic recalls these specific models due to potential weld cracks that could cause failure during the leak check step in manufacturing.
Check if your defibrillator has the model number DDMC3D4 and one of the listed serial numbers or GTINs provided in the recall notice.
If your defibrillator is not listed, it is not affected by this recall and no action is needed.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2199-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2199-2024 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.
