Medtronic recalls certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) due to a rare risk of reduced or no energy output during high voltage therapy. This could affect device function during critical medical events.
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) and cardiac resynchronization therapy defibrillators (CRT-Ds) because a rare issue with the internal glassed feedthrough could cause reduced or no energy output during high voltage therapy. This might prevent the device from working properly when needed in emergencies.
The device uses a specific type of glassed feedthrough that can occasionally fail to deliver sufficient energy during high voltage therapy (typically 0-12 joules). This rare issue might prevent the device from properly treating life-threatening heart rhythms.
People with Medtronic ICDs or CRT-Ds that match the model numbers and serial numbers listed in the recall. Those with these devices are most at risk if they experience a medical emergency requiring the device to function.
Check if your device is labeled as CRTD CROME HF MRI IS1 DF1 with model number DTPC2D1. Look for the GTIN 00763000178307 or 00763000178321, and serial numbers starting with RTX600... as listed in the recall.
Verify your device model and serial number against the list provided in the recall to confirm if it is affected.
The recall only applies to specific models and serial numbers. If your device does not match the listed details, it is not affected.
This is a rare issue that could cause reduced or no energy output during high voltage therapy, but it does not typically cause immediate harm. The risk is low and only occurs under specific conditions.
Yes, you can continue using your device normally. The recall does not require immediate action, but you should check your device details to confirm if it is affected.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1785-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1785-2023 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.
