Medtronic recalls ICDs and CRT-Ds with specific glassed feedthroughs that may cause reduced or no energy output during high voltage therapy. Affected models include CROME DR MRI IS1 DF4 with model number DDPC3D4. Owners should contact Medtronic for details.
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) that have a glassed feedthrough. This rare issue could lead to reduced or no energy output during high voltage therapy, potentially affecting device function. The recall is for specific model numbers and serial numbers.
The hazard involves a rare potential for reduced or no energy output during high voltage therapy (typically 0-12J) in devices with a specific glassed feedthrough. This could impact the device's ability to deliver necessary electrical therapy for heart rhythm management.
People with Medtronic ICDs or CRT-Ds that have the specific glassed feedthrough described in the recall are affected. Most at risk are those with these devices who use them regularly.
Check if your device is labeled as CROME DR MRI IS1 DF4 with model number DDPC3D4. Look for the GTIN 00763000178437 or the listed serial numbers (RSQ600736S, RSQ600745S, and other codes).
Reach out to Medtronic directly to confirm if your device is affected and get instructions on next steps.
Check if your device is labeled as CROME DR MRI IS1 DF4 with model number DDPC3D4 and has one of the listed serial numbers or GTIN codes.
Contact Medtronic directly to confirm your device's status and get instructions on next steps.
The recall states a rare potential for reduced or no energy output during high voltage therapy, but it does not indicate 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-1728-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1728-2023 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.
