Medtronic's ICD COBALT XT DR MRI IS1 DF1 models (DDPA2D1) with certain serial numbers may have reduced energy output during high voltage therapy. This rare issue could affect device function. Owners should check their serial numbers against the list provided.
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 ICD COBALT XT DR MRI IS1 DF1 models (model number DDPA2D1) with specific serial numbers may have a rare risk of reduced or no energy output during high voltage therapy. This could potentially affect the device's ability to treat heart conditions. If you own one of these models, check your serial number against the provided list.
The device uses a glassed feedthrough that may cause reduced or no energy output during high voltage therapy (typically 0-12J). This is a rare issue that could affect the device's ability to deliver necessary shocks for heart conditions.
People with Medtronic ICD COBALT XT DR MRI IS1 DF1 implants (model DDPA2D1) who have the listed serial numbers. The risk is rare and only affects specific models.
Check if your device is a Medtronic ICD COBALT XT DR MRI IS1 DF1 model with serial numbers listed in the provided list (e.g., RSL602442S, RSL601336S, etc.). The model number is DDPA2D1.
Compare your device's serial number with the list of affected serial numbers provided in the recall notice.
The affected devices are Medtronic ICD COBALT XT DR MRI IS1 DF1 models with model number DDPA2D1.
Check your device's serial number against the list of affected serial numbers provided in the recall notice (e.g., RSL602442S, RSL601336S, etc.).
If your device's serial number is not on the list, it is not affected by this recall and no action is needed.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1721-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1721-2023 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.
