Medtronic recalls specific implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with a rare potential for reduced or no energy output during high voltage therapy, which may affect treatment effectiveness.
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) that have a rare potential for reduced or no energy output during high voltage therapy. This could affect the device's ability to treat heart conditions effectively.
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, potentially reducing treatment effectiveness.
Patients with Medtronic implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with the specific glassed feedthrough described in the recall are affected. Most patients are not at immediate risk.
Check your device model number: DTPA2Q1. Look for the specific lot and serial numbers listed in the recall (RTD602437S, RTD602300S, and other serial numbers provided in the record).
Verify your device model number is DTPA2Q1 and check if your lot or serial number matches the list provided in the recall.
If your device is affected, contact Medtronic directly for further instructions on next steps.
This recall involves a rare potential for reduced or no energy output during high voltage therapy, which could affect treatment effectiveness. However, the risk is low and not immediate for most patients.
Check your device model number (DTPA2Q1) and compare your lot or serial number against the list of affected numbers provided in the recall.
Contact Medtronic directly for further instructions on next steps. The recall does not require immediate action for most patients.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1778-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1778-2023 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.
