Medtronic recalls specific model implantable defibrillators due to potential weld cracks causing manufacturing failures. Affected units have unique serial numbers and GTINs. 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 implantable cardioverter defibrillators (ICDs) because a manufacturing defect may cause weld cracks that fail during quality checks. This could lead to device malfunction if the device is used.
The devices may have a weld crack that fails during the leak check step in manufacturing. This defect could cause the device to malfunction if it is used, potentially leading to health risks.
People with the recalled implantable cardioverter defibrillators (ICDs) are affected. Those who have the specific model numbers and serial numbers listed in the recall are most at risk.
Check your device's serial number and GTIN. The recalled models include specific serial numbers like RTS605244S and GTINs such as 00763000178253.
Identify your device's serial number and GTIN to see if it matches the recalled units listed in the notice.
Medtronic recalls these specific models due to a potential manufacturing defect that could cause weld cracks, leading to device failure during quality checks.
Check your device's serial number and GTIN against the list provided in the recall notice. Affected units have specific serial numbers like RTS605244S and GTINs such as 00763000178253.
The recall notice does not specify a remedy, so contact Medtronic directly for further instructions.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2195-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2195-2024 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.