Medtronic recalls specific implantable defibrillators due to potential welding cracks causing manufacturing failures. Affected models include DTPA2D1 with serial numbers starting with RTH608902S.
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Medtronic is recalling certain implantable cardioverter defibrillators (COBALT XT HF CRT-D MRI SureScan) because a manufacturing defect may cause welding cracks that fail during quality checks. This could lead to device malfunction if the device is used in a patient.
The devices may have a welding crack that causes failure during the leak check step in manufacturing. This defect could lead to device malfunction if the device is used in a patient.
Patients with the recalled implantable cardioverter defibrillators are affected. Those who have the specific model numbers listed in the recall are at risk.
Check for the model number DTPA2D1 on the device. Look for serial numbers starting with RTH608902S, RTH608907S, RTH608911S, RTH608923S, RTH608935S, RTH608966S, or RTH609509S, RTH609510S.
Identify the model number and serial numbers on your device to confirm if it is affected.
Medtronic recalls these devices due to a potential manufacturing defect that could cause welding cracks, leading to failure during the leak check step in manufacturing.
Check the model number and serial numbers on your device to see if it is affected. If it is, contact Medtronic for further instructions.
The recall indicates a potential manufacturing defect that could cause device failure, but the specific risk to patients is not clearly described in the notice.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2191-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2191-2024 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.