Medtronic recalls certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with model DVMC3D1 due to rare potential for reduced or no energy output during high voltage therapy. This may affect device function during critical medical events.
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 models of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that have a rare risk of not delivering proper energy during high voltage therapy. This could potentially cause the device to fail when needed in emergencies.
The device uses a specific glassed feedthrough that can sometimes fail during high voltage therapy (typically 0-12J). This may result in reduced or no energy delivery to the heart, which could be critical during medical emergencies requiring the device to function.
People with Medtronic ICD-VR DVMC3D1 models who have the device implanted. The risk is rare and only occurs under specific high voltage therapy conditions.
Check your device model number and lot/serial numbers. The affected models are ICD-VR DVMC3D1 with lot/serial numbers listed in the recall (e.g., CWF606066S, CWF601772S).
Identify your device model number and lot/serial numbers to see if they match the recalled list (e.g., CWF606066S, CWF601772S).
If your device is affected, contact Medtronic directly for further instructions on device evaluation or potential replacement.
This recall addresses a rare potential for reduced or no energy output during high voltage therapy. The risk is very low and only occurs under specific conditions, not during normal use.
Check your device model number and lot/serial numbers against the list provided in the recall (e.g., CWF606066S, CWF601772S).
No, the recall does not require removal of the device. Affected devices should be evaluated by Medtronic for potential 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-1812-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1812-2023 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.
