Medtronic recalls certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with a specific glassed feedthrough that may cause reduced or no energy output during high voltage therapy. This rare issue 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 certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that have a specific glassed feedthrough. This rare issue could cause the device to not deliver enough energy during high voltage therapy, potentially affecting critical heart rhythm treatments. Affected devices may need replacement.
The device uses a glassed feedthrough that can sometimes fail to deliver sufficient energy during high voltage therapy (typically 0-12J). This rare issue may cause the device to not function properly during critical heart rhythm treatments, potentially affecting the device's ability to treat life-threatening arrhythmias.
Patients with Medtronic implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with the specific glassed feedthrough are most at risk. This recall affects a limited number of devices.
Check your device model: CRTD COBALT HF MRI IS1 DF4 with model number DTPB2D4. Look for GTIN 00763000178215 and lot serial numbers listed in the recall (e.g., RTO600161S, RTO600247S).
Identify your device model by checking the label on the device or its packaging for the model number DTPB2D4.
Reach out to Medtronic directly to confirm if your device is affected and to get instructions for replacement or repair.
This is a rare issue that may cause reduced or no energy output during high voltage therapy. The risk is low as it affects a limited number of devices and does not typically cause serious injury.
Check your device model: CRTD COBALT HF MRI IS1 DF4 with model number DTPB2D4. Look for GTIN 00763000178215 and lot serial numbers listed in the recall (e.g., RTO600161S, RTO600247S).
Medtronic will contact affected patients to provide instructions for replacement or repair. You do not need to take immediate action unless your device is confirmed affected.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1782-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1782-2023 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.
