Medtronic recalls specific Cobalt XT HF CDT-D MRI SureScan defibrillators with model DTPA2D4 due to potential welding 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 certain implantable cardioverter defibrillators (Cobalt XT HF CDT-D MRI SureScan) with model number DTPA2D4 because a manufacturing defect may cause welding cracks that fail during leak checks. This could lead to device malfunction in some cases.
A welding crack in the device during manufacturing could cause it to fail at the leak check step. This defect might lead to the device not working properly, but it does not cause immediate harm to the user.
People with the specific model number DTPA2D4 implantable cardioverter defibrillator (ICD) are affected. Those who have this device implanted and are using it for medical treatment are most at risk.
Check your device's model number, which is DTPA2D4. Look for the specific serial numbers listed: RTG612496S through RTG612556S. The GTIN number is 00763000178130.
Verify your device has model number DTPA2D4 and one of the listed serial numbers.
The recall does not require stopping use; the device is safe to continue using as long as it has the correct model and serial numbers.
Check for model number DTPA2D4 and one of the serial numbers: RTG612496S, RTG612497S, RTG612498S, RTG612499S, RTG612502S, RTG612503S, RTG612504S, RTG612505S, RTG612509S, RTG612512S, RTG612513S, RTG612549S, RTG612553S, or RTG612556S.
The recall does not include a remedy; you should check with your doctor or Medtronic to confirm if your device is affected and 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-2192-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2192-2024 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.