Medtronic recalls certain CRT-D defibrillators (model DTBB1D4) due to rare potential for reduced or no energy output during high voltage therapy, which could affect heart rhythm treatment.
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) because they may not deliver proper energy during high voltage therapy, potentially affecting heart rhythm treatment. This rare issue could lead to inadequate treatment if the device fails to function correctly.
The recalled CRT-D devices have a specific glassed feedthrough that may cause reduced or no energy output during high voltage therapy (typically 0-12J). This could lead to inadequate treatment of heart rhythm issues if the device fails to deliver the necessary electrical energy.
People with implantable cardioverter defibrillators (CRT-Ds) using the recalled model numbers (DTBB1D4) are affected. Those with the specific lot and serial numbers listed in the recall are most at risk.
Check your device's model number, which is DTBB1D4. Look for the lot and serial numbers listed in the recall (e.g., BLN205385H) on the device's label or documentation. The product was sold in the US with GTIN 00643169720268.
Identify your device's model number to see if it matches DTBB1D4.
Reach out to Medtronic directly for guidance on whether your device is affected and next steps.
The recall describes a rare potential for reduced or no energy output during high voltage therapy, which could affect heart rhythm treatment. However, this is not a common issue and the risk is low.
Check your device's model number (DTBB1D4) and lot/serial numbers against the list provided in the recall. The specific numbers are listed in the recall document.
Contact Medtronic directly for guidance on whether your device is affected and next steps. The recall does not specify a replacement or repair process.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1742-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1742-2023 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.
