Medtronic recalls certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured 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 use a specific glassed feedthrough. This rare issue could cause the device to not deliver enough energy during high voltage therapy, potentially affecting treatment effectiveness. If you have one of these devices, you should contact Medtronic for further instructions.
The device uses a glassed feedthrough that can occasionally fail during high voltage therapy (typically 0-12J). This may result in reduced or no energy output when the device needs to shock the heart, potentially affecting treatment effectiveness during critical medical events.
People with Medtronic ICDs or CRT-Ds that have the specific glassed feedthrough (model DTPA2D1) are affected. Most users are at low risk as this is a rare issue that doesn't typically cause serious injury.
Check if your device has the model number DTPA2D1 and lot/serial numbers listed in the recall (e.g., RTH601483S, RTH602021S, etc.). The device is an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
Identify your device model number (DTPA2D1) and lot/serial numbers from the recall list.
Reach out to Medtronic for specific instructions on whether your device needs repair or replacement.
This is a rare issue that may cause reduced or no energy output during high voltage therapy, but it does not typically cause serious injury. Most users are at low risk.
Check if your device has the model number DTPA2D1 and lot/serial numbers listed in the recall (e.g., RTH601483S, RTH602021S, etc.).
No, the recall does not require removal of the device. Contact Medtronic for specific instructions on whether your device needs repair or replacement.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1774-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1774-2023 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.
