Medtronic recalls specific implantable defibrillators (CRTD CROME HF MRI IS1 DF4 model DTPC2D4) due to rare potential for reduced or no energy output during high voltage therapy. This may affect device function but is not immediately dangerous.
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 defibrillators that have a rare risk of reduced or no energy output during high voltage therapy. This could cause the device to fail to treat heart arrhythmias, but the risk is very low and not immediately dangerous.
The device uses a specific glassed feedthrough that can occasionally cause reduced or no energy output during high voltage therapy (typically 0-12J). This may prevent the device from properly treating heart arrhythmias, but the risk is rare and not immediately life-threatening.
People with implantable defibrillators (ICDs or CRT-Ds) that match the specific model and serial numbers listed in the recall. Those with the device are most at risk.
Check if your device is labeled as CRTD CROME HF MRI IS1 DF4 with model number DTPC2D4. Look for the GTIN 00763000178291 or GTIN 00763000178314, and serial numbers starting with RTW600... as listed in the recall.
Review your device's model number and serial number to see if they match the recalled items listed in the recall notice.
The recall states there is a rare potential for reduced or no energy output during high voltage therapy, but it is not immediately dangerous and does not cause serious injury in normal use.
You do not need to take immediate action. Check your device details against the list provided in the recall notice to see if it is affected.
If your device matches the recalled model and serial numbers, contact Medtronic directly for further instructions. They may provide a 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-1786-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1786-2023 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.
