Medtronic recalls CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 models with specific glassed feedthroughs. Rare potential for reduced or no energy output during high voltage therapy may cause device malfunction. Check serial numbers listed in the recall.
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 CRT-D (cardiac resynchronization therapy defibrillators) models that have a rare potential for reduced or no energy output during high voltage therapy. This could cause the device to malfunction and not deliver necessary shocks. Affected models have specific serial numbers and GTINs listed in the recall.
The device uses a specific type of glassed feedthrough that can occasionally fail during high voltage therapy (0-12J). This may cause the device to not deliver enough energy to treat heart conditions, potentially leading to device malfunction.
People with Medtronic CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 implants are most at risk. This recall affects specific serial numbers and GTINs listed in the notice.
Check if your device has the model number DTBC2Q1 and serial numbers starting with BLY60 followed by 5 digits (e.g., BLY602416S). Also check for GTIN 00643169720244 or 00643169980198.
Look for the model number DTBC2Q1 on your device's label or documentation.
Check if your device's serial number starts with BLY60 followed by 5 digits (e.g., BLY602416S).
If your device is affected, contact Medtronic directly for further instructions.
This recall involves a rare potential for reduced or no energy output during high voltage therapy, which could cause device malfunction. However, it is not a common issue and does not typically cause serious injury.
Check if your device has the model number DTBC2Q1 and serial numbers starting with BLY60 followed by 5 digits (e.g., BLY602416S). Also check for GTIN 00643169720244 or 00643169980198.
Contact Medtronic directly for further instructions. They will provide details on how to proceed with the recall.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1751-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1751-2023 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.
