Medtronic's ICD COBALT XT DR MRI IS1 DF4 models (DDPA2D4) have a rare risk of reduced or no energy output during high voltage therapy. Affected units include specific serial numbers listed in the recall. Contact Medtronic for replacement.
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
Medtronic's COBALT XT DR MRI IS1 DF4 implantable cardioverter defibrillators (ICDs) have a rare risk of reduced or no energy output during high voltage therapy. This could potentially cause the device to fail when needed. Affected units have specific serial numbers listed in the recall.
The device uses a specific type of glassed feedthrough that can sometimes fail during high voltage therapy (0-12J). This may result in reduced or no energy output when the device needs to shock the heart, which could be serious in rare cases.
Patients with Medtronic COBALT XT DR MRI IS1 DF4 ICDs (model DDPA2D4) who have the specific serial numbers listed in the recall are affected. Most patients with these devices are at low risk as the issue is rare and only affects a small number of units.
Check your ICD's model number (DDPA2D4) and serial number against the list of affected units provided in the recall. The recall includes a specific list of serial numbers.
Verify your ICD model number and serial number against the list of affected units provided in the recall.
If your device is affected, contact Medtronic directly for instructions on replacement or repair.
Check your ICD's model number (DDPA2D4) and serial number against the list of affected units provided in the recall.
If your device is affected, Medtronic will provide instructions for replacement or repair.
The issue is rare and only affects a small number of units. Most patients with these devices are at low risk as the problem does not cause immediate harm in normal use.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1723-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1723-2023 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.
