Medtronic recalls certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) due to rare potential for reduced or no energy output during high voltage therapy. This may affect devices with specific glassed feedthroughs.
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 rare potential for reduced or no energy output during high voltage therapy. This could cause the device to fail to deliver necessary shocks in emergencies.
The device has a specific glassed feedthrough that can cause reduced or no energy output during high voltage therapy (typically 0-12J). This means the device might not deliver necessary shocks during critical heart rhythm emergencies, potentially leading to life-threatening situations.
People with Medtronic implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific glassed feedthrough. Most users are unlikely to experience issues, but the rare failure could be serious.
Check your device's model number: CRTD COBALT HF MRI IS1 DF1. Look for the model number DTPB2D1. The lot serial numbers listed in the recall include many combinations starting with RTP600... or RTP601... followed by a number and S.
Identify your device model by checking the label on the device or its packaging. The model number should be DTPB2D1 for the recalled devices.
If your device is listed in the recall, contact Medtronic directly for instructions on how to proceed with the recall.
This recall addresses a rare potential for reduced or no energy output during high voltage therapy. While serious, it is uncommon and most users will not experience issues.
Check your device model number. The recalled devices have model number DTPB2D1 and lot serial numbers starting with RTP600 or RTP601 followed by a number and S.
Contact Medtronic directly for instructions on how to proceed with the recall. They will provide specific steps for affected devices.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1781-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1781-2023 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.