Medtronic recalls specific Implantable Cardioverter Defibrillators (PRIMO MRI DR SureScan Model DDMD3D1) due to potential weld cracks causing manufacturing failures. Affected units have unique serial numbers and GTIN.
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Medtronic is recalling a specific model of implantable defibrillator (PRIMO MRI DR SureScan, Model DDMD3D1) because a manufacturing defect may cause weld cracks that fail during quality checks. This could lead to device malfunction if the defect isn't caught early.
The device may have a weld crack that fails during the leak check step in manufacturing. This defect could cause the device to malfunction if not detected during production, potentially leading to improper function.
People with the specific model of implantable defibrillator (PRIMO MRI DR SureScan, Model DDMD3D1) are affected. Those who have the device implanted and are using it regularly are most at risk.
Check for the model number DDMD3D1 on the device. Affected units have serial numbers CWM605634S or CWM605635S and GTIN 00763000611910.
Look for serial numbers CWM605634S or CWM605635S on the device.
The recall is due to a potential manufacturing defect that could cause failure during quality checks, but the device may still function safely if the defect is not present.
Check for the model number DDMD3D1 and serial numbers CWM605634S or CWM605635S on the device.
The recall does not specify a remedy, so contact Medtronic directly for guidance on 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-2200-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2200-2024 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.
