Medtronic recalls specific model implantable defibrillators due to potential weld cracks causing manufacturing failures. Affected units have unique serial numbers; contact Medtronic for details.
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Medtronic is recalling certain Evera MRI S VR SureScan 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.
A manufacturing defect may cause weld cracks in the device. These cracks can lead to the device failing during the leak check step in manufacturing, potentially causing malfunction if the device is used.
People with an implantable cardioverter defibrillator (ICD) that matches the specific serial numbers listed. Those who have the device implanted and are using it regularly are most at risk.
Check the serial number on your device. Affected units have serial numbers starting with PMZ646287S through PMZ646307S. The device model is Evera MRI S VR SureScan with manufacturer code DVMC3D4.
Look for the serial number on your device, which should be one of the listed numbers starting with PMZ646287S through PMZ646307S.
Reach out to Medtronic directly for further instructions on whether your device is affected and what to do next.
Medtronic recalls these specific models due to a potential manufacturing defect that may cause weld cracks, leading to device failure during the leak check step in manufacturing.
Check the serial number on your device. If it matches the listed numbers, contact Medtronic for further instructions.
The recall states a potential manufacturing defect could cause device failure, but the official notice does not specify if this defect leads to 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-2197-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2197-2024 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.
