Medtronic recalls certain CRT-D devices with model DTBB1Q1 for rare risk of reduced energy output during high voltage therapy. Affected units include specific serial numbers and lot numbers.
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) due to a rare risk of reduced or no energy output during high voltage therapy. This could potentially lead to ineffective treatment of heart conditions if the device fails to deliver necessary shocks.
The device uses a specific glassed feedthrough that may cause reduced or no energy output during high voltage therapy (typically 0-12J). This could result in the device failing to deliver necessary shocks during critical heart events.
People with Medtronic CRT-D devices (model DTBB1Q1 VIVA QUAD S IS4/DF1) manufactured in the US. Those with heart conditions requiring a defibrillator are most at risk.
Check for the model number DTBB1Q1 VIVA QUAD S IS4/DF1 on the device. Look for serial numbers starting with BLM2028xx through BLM2030xx as listed in the recall notice.
Identify the model number on your device, which should be DTBB1Q1 VIVA QUAD S IS4/DF1.
Confirm your device's serial number starts with BLM2028xx through BLM2030xx as listed in the recall notice.
The recall describes a rare potential for reduced or no energy output during high voltage therapy, which could affect treatment effectiveness but is not expected to cause immediate harm.
Check the model number on your device (DTBB1Q1 VIVA QUAD S IS4/DF1) and verify the serial number starts with BLM2028xx through BLM2030xx as listed in the recall notice.
The recall does not specify a remedy, so contact Medtronic directly for guidance on next steps.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1743-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1743-2023 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.
