Medtronic recalls CRT-D DTBB2D1 VIVA S models with specific serial numbers due to rare risk of reduced or no energy output during high voltage therapy, potentially affecting heart rhythm devices.
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 defibrillator) models that use a specific glassed feedthrough. These devices have a rare risk of not delivering enough energy during high voltage therapy, which could lead to ineffective treatment. Affected units have specific serial numbers and GTINs listed in the recall.
The recall involves a rare potential for reduced or no energy output during high voltage therapy (typically 0-12J) in devices with a specific glassed feedthrough. This could mean the device fails to deliver necessary shocks during critical heart rhythm events, potentially leading to ineffective treatment.
People with Medtronic CRT-D devices that have the specific serial numbers or GTINs listed in the recall are affected. Most users of these devices are patients with heart conditions requiring implantable defibrillators.
Check if your device has the model number DTBB2D1 VIVA S IS1/DF1 INTL. Look for the GTIN 00643169720350 or 00643169980105, and serial numbers starting with BLS604... or BLS605... as listed in the recall.
Identify your device model and serial number to see if it matches the recalled units listed in the recall notice.
Reach out to Medtronic directly for guidance on next steps if your device is affected.
The recall describes a rare potential for reduced or no energy output during high voltage therapy, which could affect treatment effectiveness. However, this is not a common hazard and does not pose an immediate risk of serious injury.
Check if your device has the model number DTBB2D1 VIVA S IS1/DF1 INTL and the specific serial numbers or GTINs listed in the recall notice.
Contact Medtronic directly for guidance on next steps. The recall does not specify a replacement or repair process, only that affected devices should be checked.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1745-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1745-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
