Medtronic recalls specific implantable cardioverter defibrillators (CRTD VIVA QUAD XT CUST PARY GOLD) due to rare potential for reduced or no energy output during high voltage therapy. This could affect device function but is not common.
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 (CRTD VIVA QUAD XT CUST PARY GOLD) because of a rare risk that the device might not deliver enough energy during high voltage therapy. This could lead to the device failing to treat heart conditions as intended, though the risk is very low and not common.
The device uses a specific type of glassed feedthrough that can occasionally fail to deliver the required energy during high voltage therapy. This rare issue might cause the device to stop working properly when needed, but it does not cause immediate harm.
People with implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) who own the specific model and lot numbers listed. Those with the device are most at risk.
Check if your device has the model number DTBA1QQPG and lot/serial numbers listed: BLC229283H, BLC229226H, BLC229270H, BLC229280H, BLC229229H, BLC228997H, BLC229238H, BLC229043H, BLC229231H, BLC229046H, BLC229045H, BLC229230H, BLC228995H, BLC229010H.
Verify your device model number is DTBA1QQPG and lot/serial numbers match the list provided in the recall.
This is a rare issue that could cause the device to not deliver enough energy during high voltage therapy, but it does not cause immediate harm or serious injury.
Check if your device has the model number DTBA1QQPG and lot/serial numbers listed: BLC229283H, BLC229226H, BLC229270H, BLC229280H, BLC229229H, BLC228997H, BLC229238H, BLC229043H, BLC229231H, BLC229046H, BLC229045H, BLC229230H, BLC228995H, BLC229010H.
The recall does not require immediate action, but you should check your device model and lot numbers to see if it 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-1734-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1734-2023 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.