Medtronic recalls certain implantable cardioverter defibrillators (ICDs) with model DVPA2D4 that may have reduced energy output during high voltage therapy. This rare issue could affect device function but does not cause immediate harm. Owners should check their lot 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 specific implantable cardioverter defibrillators (ICDs) with model number DVPA2D4 that have a rare potential for reduced or no energy output during high voltage therapy. This could affect the device's ability to deliver necessary shocks but is not expected to cause immediate injury.
The device uses a specific glassed feedthrough that can cause reduced or no energy output during high voltage therapy (typically 0-12J). This may affect the device's ability to deliver necessary shocks during cardiac emergencies, but it is a rare occurrence and does not cause immediate injury.
People with Medtronic ICD COBALT XT VR MRI DF4 devices (model DVPA2D4) manufactured with a specific glassed feedthrough. Most users are not at risk as this is a rare issue.
Check your device's model number (DVPA2D4) and lot/serial numbers listed in the recall: RSD605765S, RSD605767S, and other codes ending with 'S' as shown in the full list.
Identify your device model as DVPA2D4 and check if your lot/serial number is in the list provided in the recall.
If your device is affected, contact Medtronic directly for further instructions. They may provide a replacement or repair.
This is a rare issue that may cause reduced or no energy output during high voltage therapy, but it does not cause immediate injury. Most users are not at risk.
Check your device model number (DVPA2D4) and lot/serial number against the list of affected numbers provided in the recall.
No action is needed if your device model and lot/serial number are not in the affected list.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1819-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1819-2023 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.