Medtronic's implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with model DTMC2D1 may have reduced or no energy output during high voltage therapy. Affected units include specific serial numbers listed in the recall. Contact Medtronic for details.
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 is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with model number DTMC2D1 due to a rare risk of reduced or no energy output during high voltage therapy. This could potentially affect the device's ability to deliver life-saving shocks in emergencies.
The device uses a glassed feedthrough that can sometimes fail to deliver sufficient energy during high voltage therapy (typically 0-12 joules). This is a rare occurrence but could lead to the device not functioning properly when needed in critical situations.
Patients with Medtronic ICDs or CRT-Ds manufactured with the specific DTMC2D1 model and listed serial numbers are affected. The risk is rare and occurs only during high voltage therapy, which is not typically used in everyday operation.
Check if your device has the model number DTMC2D1 and the listed serial numbers (e.g., RPR605458S, RPR606698S, etc.) from the recall list. The device is an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
Verify your device's model number is DTMC2D1 and check if it matches the listed serial numbers in the recall.
Reach out to Medtronic directly for specific instructions on whether your device is affected and what actions to take.
This is a rare risk that could affect the device's ability to deliver energy during high voltage therapy, but it does not pose an immediate danger in normal use.
Check if your device has the model number DTMC2D1 and one of the listed serial numbers (e.g., RPR605458S, RPR606698S, etc.).
No action is required if your device is not listed in the recall. You can continue using it as normal.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1771-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1771-2023 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.
