Medtronic recalls ICD CROME VR MRI DF4 model DVPC3D4 devices with specific lot/serial numbers due to rare potential for reduced or no energy output during high voltage therapy, which could affect heart rhythm management.
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) and cardiac resynchronization therapy defibrillators (CRT-Ds) with model number DVPC3D4. These devices have a rare potential for reduced or no energy output during high voltage therapy, which could compromise heart rhythm management. This recall affects specific lot and serial numbers listed in the notice.
The hazard involves a rare potential for reduced or no energy output during high voltage therapy (typically 0-12J) in these devices. This could lead to inadequate heart rhythm management if the device fails to deliver necessary electrical impulses during critical medical events.
People with Medtronic ICDs or CRT-Ds manufactured with the specific glassed feedthrough (model DVPC3D4) are most at risk. This recall affects individuals who have the listed lot and serial numbers.
Check your device model number (DVPC3D4) and lot/serial numbers against the list provided in the recall notice. The GTIN is 00763000178550 or 00763000178567 with specific lot and serial numbers listed.
Identify your device model number (DVPC3D4) and compare it to the list of affected models in the recall notice.
Check your device's lot and serial numbers against the provided list of affected serial numbers to determine if your device is included.
This recall affects Medtronic ICDs and CRT-Ds with model number DVPC3D4 and specific lot/serial numbers listed in the notice. Check your device model and numbers against the provided list.
If your device is listed in the recall, contact Medtronic directly for further instructions. The recall does not require immediate action but you should verify your device status.
The hazard is rare and only affects high voltage therapy output. Medtronic states this is a potential for reduced or no energy output, but not a risk of serious injury in normal use.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1823-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1823-2023 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.
