Medtronic recalls specific Implantable Cardioverter Defibrillators (COBALT XT HF QUAD CRT-D MRI SureScan) with model DTPA2QQ due to potential welding cracks causing device failure during manufacturing leak checks.
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) with model number DTPA2QQ because a manufacturing defect may cause the device to fail during quality control testing. This could lead to device malfunction if the device is implanted in a patient.
The recall is due to a potential welding crack in the device that could cause it to fail during the leak check step in manufacturing. This defect might lead to device malfunction if the device is implanted in a patient.
Patients with the recalled Implantable Cardioverter Defibrillator model DTPA2QQ are affected. Those who have this specific device implanted are most at risk.
Check for the model number DTPA2QQ on the device. The serial numbers listed in the recall include RTC656756S and other specific serial numbers provided in the recall notice.
Look for the model number DTPA2QQ on the device label.
Reach out to Medtronic directly for further assistance with the recall.
The recall states that the defect could cause device failure during manufacturing leak checks, but it does not specify if an implanted device is immediately dangerous.
Check the model number DTPA2QQ and the specific serial numbers listed in the recall notice.
The recall does not provide a specific remedy, so contact Medtronic directly for guidance.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2194-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2194-2024 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.