Medtronic recalls certain implantable cardioverter defibrillators (ICDs) due to rare risk of reduced or no energy output during high voltage therapy. Affected devices include specific model numbers and serial lots.
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 may have a rare issue causing reduced or no energy output during high voltage therapy. This could potentially affect the device's ability to treat heart conditions effectively.
The device uses a specific type of glassed feedthrough that may occasionally fail to deliver the full energy needed for high voltage therapy. This is a rare occurrence but could lead to reduced effectiveness of the device in treating heart conditions.
People with implanted Medtronic ICDs or CRT-Ds (cardiac resynchronization therapy defibrillators) that match the specific model numbers and serial lots listed in the recall. Those with the affected devices are most at risk.
Check your device's model number (DVAC3D1), serial numbers (BWU600xxxS format), and lot numbers (BWU600776S, BWU600721S, etc.) against the list provided in the recall notice. The recall covers specific devices manufactured with a glassed feedthrough.
Review your device's model number, serial number, and lot number to confirm if it matches the recalled items listed in the notice.
No action is needed if your device's model, serial, or lot numbers do not match the recalled items listed in the notice.
This is a rare potential issue that may cause reduced or no energy output during high voltage therapy, but it does not typically cause serious injury or death.
The recall does not include a specific remedy or action for affected devices. You should contact Medtronic directly for further guidance.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1793-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1793-2023 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.
