Medtronic recalls CRT-D VIVA QUAD S IS4/DF4 INTL model DTBB2QQ with rare risk of reduced or no energy output during high voltage therapy. Affected units have specific serial numbers and GTINs.
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 (CRT-Ds) due to a rare risk of reduced or no energy output during high voltage therapy. This could potentially cause the device to fail when needed in emergencies.
The device uses a specific type of glassed feedthrough that can cause reduced or no energy output during high voltage therapy (typically 0-12J). This means the device might not function properly when needed to treat life-threatening heart rhythms.
People with Medtronic CRT-D VIVA QUAD S IS4/DF4 INTL model DTBB2QQ implants are affected. Those with the specific serial numbers and GTINs listed in the recall are most at risk.
Check if your device is labeled as 'CRT-D VIVA QUAD S IS4/DF4 INTL' with model number DTBB2QQ. Look for the specific serial numbers and GTINs listed in the recall notice.
Identify your device model by checking the label on the device or its packaging for 'CRT-D VIVA QUAD S IS4/DF4 INTL' with model number DTBB2QQ.
Compare your device's serial number against the list of affected serial numbers and GTINs provided in the recall notice.
The recall describes a rare potential for reduced or no energy output during high voltage therapy, which could cause the device to fail when needed in emergencies.
Check if your device is labeled as 'CRT-D VIVA QUAD S IS4/DF4 INTL' with model number DTBB2QQ and compare your serial number against the list of affected serial numbers and GTINs provided in the recall notice.
The recall does not specify a remedy, so affected users should contact Medtronic directly for further instructions.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1748-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1748-2023 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.
