Medtronic recalls CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US models with specific serial numbers due to rare risk of reduced or no energy output during high voltage therapy. Affected devices may require replacement.
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 affect the device's ability to properly treat heart conditions.
The device uses a specific type of glassed feedthrough that can occasionally fail to deliver proper energy during high voltage therapy (0-12 joules). This rare issue may cause the device to not function correctly when needed for heart treatment.
People with implanted CRT-D devices that match the specific model and serial numbers listed in the recall. Most users are not at risk as this is a rare issue.
Check if your device has model number DTBA1QQ and serial numbers starting with BLC228... or BLC600... as listed in the recall. This is an implantable device, so you'll need to contact your doctor for verification.
Your doctor will confirm if your device is affected and guide you on next steps.
This is a rare issue that may cause reduced or no energy output during high voltage therapy, but it does not cause immediate harm. Most devices function safely.
Check if your device has model number DTBA1QQ and serial numbers starting with BLC228... or BLC600... as listed in the recall. You'll need to contact your doctor for confirmation.
The recall does not specify replacement; your doctor will determine if action is needed based on your specific device.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1733-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1733-2023 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.