Medtronic recalls certain implantable cardioverter defibrillators (ICDs) due to rare risk of reduced or no energy output during high voltage therapy. Affected models include DVEX3E4 with specific serial numbers.
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) that have a rare potential for reduced or no energy output during high voltage therapy. This could affect the device's ability to properly treat heart conditions.
The device uses a glassed feedthrough component that can occasionally fail to deliver sufficient energy during high voltage therapy (typically 0-12 joules). This rare issue might prevent the device from effectively treating heart conditions.
People with Medtronic ICDs or CRT-Ds (cardiac resynchronization therapy defibrillators) that match the specific model and serial numbers listed in the recall. Those with these devices are most at risk.
Check if your device is labeled as ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL with model number DVEX3E4. Look for the specific serial numbers listed in the recall (e.g., EVS600719S, EVS600271S, etc.) or GTIN 00763000217891 and 00763000217907.
Identify your device model and serial numbers by checking the device label or documentation.
Reach out to Medtronic directly to confirm if your device is affected and get instructions for next steps.
This recall addresses a rare potential for reduced or no energy output during high voltage therapy, which could affect the device's ability to treat heart conditions. However, the risk is low and not expected to cause serious injury in normal use.
Your device is affected if it matches the model number DVEX3E4 and has one of the specific serial numbers listed in the recall (e.g., EVS600719S, EVS600271S, etc.).
Contact Medtronic directly to confirm if your device is affected and get instructions for next steps. They may provide a replacement or repair.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1802-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1802-2023 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.
