Medtronic recalls Evera MRI S DR SureScan defibrillators with model DDMC3D1 due to potential weld cracks causing failure during manufacturing leak checks. 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 Evera MRI S DR SureScan implantable defibrillators with model number DDMC3D1 because a manufacturing defect may cause weld cracks that fail during leak checks. This could lead to device failure if the device is used.
The device may have a weld crack from a manufacturing defect that causes it to fail during the leak check step in production. This defect could lead to device failure if the device is used.
People with an Evera MRI S DR SureScan defibrillator model DDMC3D1, identified by specific serial numbers or GTIN, are affected. Those who have the device are most at risk.
Check if your defibrillator has model number DDMC3D1 and serial numbers CWC613698S, CWC613700S, CWC613713S, CWC613715S, or CWC613717S. The GTIN is 00763000206192.
Look for model number DDMC3D1 and specific serial numbers listed in the recall notice.
The recall is for potential manufacturing defects that could cause failure during leak checks, but the device may be safe if it works properly.
Check if your device has model number DDMC3D1 and serial numbers CWC613698S, CWC613700S, CWC613713S, CWC613715S, or CWC613717S.
The recall does not specify a remedy, so contact Medtronic directly for guidance.
We’ve drafted a message you can send Medtr: The brand name from the title is to request your refund or repair — edit it as you like.
Subject: Recall Z-2198-2024 — Medtr: The brand name from the title is Medtr: The brand name from the title is Hello, I own a Medtr: The brand name from the title is that is covered by recall Z-2198-2024 from Medtr: The brand name from the title is. 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.
