Medtronic recalls certain implantable cardioverter defibrillators (ICDs) due to rare risk of reduced or no energy output during high voltage therapy, potentially affecting 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 specific implantable cardioverter defibrillators (ICDs) that may have reduced or no energy output during high voltage therapy. This could cause the device to fail to deliver necessary shocks during emergencies, putting users at risk of life-threatening heart issues.
The devices contain a specific glassed feedthrough that may cause reduced or no energy output during high voltage therapy. This could mean the device fails to deliver necessary shocks during heart emergencies, potentially leading to life-threatening complications.
People with Medtronic ICDs or CRT-Ds (cardiac resynchronization therapy defibrillators) that match the model and serial numbers listed in the recall are affected. Those with these devices are most at risk.
Check your device model number (DVEX2E4) and serial numbers (EVR600484S through EVR600526S) on the device label or packaging. These devices were sold with the GTIN 00763000115647.
Look for the model number DVEX2E4 on your device label or packaging.
Reach out to Medtronic directly to confirm if your device is affected and get guidance on next steps.
No, but you should check if your device is affected and contact Medtronic for guidance.
There is a rare potential for reduced or no energy output during high voltage therapy, which could cause the device to fail to deliver necessary shocks during heart emergencies.
Check your device model number (DVEX2E4) and serial numbers (EVR600484S through EVR600526S) on the device label or packaging.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1801-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1801-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
