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 models of implantable cardioverter defibrillators (ICDs) because they may have a rare issue where the device doesn't deliver enough energy during high voltage therapy. This could lead to the device failing to treat life-threatening heart rhythms in emergencies.
The recalled devices use a specific glassed feedthrough that can sometimes fail to deliver the required energy during high voltage therapy. This is a rare occurrence but could mean the device doesn't work properly when needed to treat sudden heart rhythm problems.
People with Medtronic ICDs or CRT-Ds (cardiac resynchronization therapy defibrillators) using the recalled model numbers are affected. Those with these devices are most at risk if the device fails during critical heart rhythm events.
Check your device's model number, which is DVMB1D4 for the recalled ICDs. The lot and serial numbers listed in the recall include PKZ2120xxH patterns. These devices were sold in the US with the GTIN 00643169720558.
Look for the model number DVMB1D4 on your implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
The recall does not require immediate stopping of use. The hazard is rare and the device may still function safely in most cases.
The recall does not specify a remedy, so contact Medtronic directly for guidance on next steps.
Check your device's model number (DVMB1D4) and lot/serial numbers against the list provided in the recall: PKZ2120xxH patterns.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1809-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1809-2023 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.
