Medtronic recalls specific models of PRIMO MRI VR SureScan implantable defibrillators due to potential welding cracks causing manufacturing failures. Affected units have unique serial numbers.
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Medtronic is recalling specific models of PRIMO MRI VR SureScan implantable defibrillators 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, but it does not indicate immediate danger during normal use.
People with a specific model of Medtronic PRIMO MRI VR SureScan implantable defibrillator (model DVMD3D4) are affected. Those who have the listed serial numbers are most at risk.
Check if your device has the model number DVMD3D4 and one of the listed serial numbers (e.g., CWL619625S, CWL619626S, etc.). The product is an implantable cardioverter defibrillator.
Verify your device has the model number DVMD3D4 and one of the listed serial numbers.
Medtronic recalls these specific models due to a potential welding crack that could cause the device to fail during leak checks in manufacturing.
Check if your device has the model number DVMD3D4 and one of the listed serial numbers (e.g., CWL619625S, CWL619626S, etc.).
The recall does not specify a remedy, so contact Medtronic directly to discuss next steps.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2203-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2203-2024 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.
