Medtronic recalls specific models of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) due to a rare risk of reduced or no energy output during high-voltage therapy, which may affect device function.
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 DTPA2D4. This recall is due to a rare potential for reduced or no energy output during high-voltage therapy, which could impact the device's ability to treat heart conditions.
The hazard involves a rare potential for reduced or no energy output during high-voltage therapy (typically 0-12J) in these devices. This could affect the device's ability to deliver necessary shocks for heart rhythm management, but the risk is described as rare and not immediately life-threatening.
People with Medtronic implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) that have the specific model number DTPA2D4 are affected. Those with the listed lot/serial numbers are most at risk.
Check your device's model number, which is DTPA2D4. Look for the specific lot and serial numbers listed in the recall notice, which include many combinations starting with RTG60.
Identify your device model number, which should be DTPA2D4 for affected units.
Reach out to Medtronic directly to confirm if your device is affected and to get instructions for next steps.
The recall describes a rare potential for reduced or no energy output during high-voltage therapy, but it is not described as an immediate risk of serious injury or death. The hazard is considered low risk.
Your device is affected if it has model number DTPA2D4 and one of the listed lot/serial numbers starting with RTG60.
Contact Medtronic directly to confirm if your device is affected and to get instructions for 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-1777-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1777-2023 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.
