Medtronic recalls certain CRT-D DTBC2D4 models (GTIN 00643169720305) due to rare potential for reduced or no energy output during high-voltage therapy, which could affect heart rhythm management.
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 (CRT-Ds) with model number DTBC2D4. These devices have a rare risk of not delivering enough energy during high-voltage therapy, which could lead to ineffective heart rhythm treatment. This is a potential safety issue for patients with heart conditions.
The hazard involves a rare potential for reduced or no energy output during high-voltage therapy (0-12J) in the device's specific glassed feedthrough. This could lead to ineffective treatment of heart rhythm issues if the device fails to deliver the required energy during critical therapy events.
Patients with implantable cardioverter defibrillators (CRT-Ds) using the recalled model DTBC2D4 are most at risk. The recall affects a specific batch of devices manufactured with a glassed feedthrough.
Check your device's model number (DTBC2D4) and lot/serial numbers listed in the recall (e.g., BLZ604044S, BLZ604109S). The GTIN is 00643169720305. If your device matches these details, it is affected.
Identify your device's model number (DTBC2D4) and lot/serial numbers from the list provided in the recall.
Reach out to Medtronic directly for guidance on next steps if your device is affected.
The recall describes a rare potential for reduced or no energy output during high-voltage therapy, which could affect heart rhythm management. However, this is not a common issue and the risk is low.
Check your device's model number (DTBC2D4) and lot/serial numbers against the list provided in the recall (e.g., BLZ604044S, BLZ604109S). The GTIN is 00643169720305.
Contact Medtronic directly for guidance on next steps if your device 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-1750-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1750-2023 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.
