Medtronic recalls CRT-D defibrillators with specific model number DTBA1D1G due to rare risk of reduced or no energy output during high voltage therapy, potentially affecting heart rhythm stability.
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 defibrillators that have a rare risk of not delivering enough energy during high voltage therapy. This could lead to heart rhythm issues if the device fails to function properly.
The device uses a specific glassed feedthrough that can occasionally fail to deliver sufficient energy during high voltage therapy. This may cause the device to not function properly when needed to treat heart rhythm problems.
Patients with implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) who own the recalled model DTBA1D1G are affected. Those with the specific lot/serial numbers BLF258300H are most at risk.
Check for the model number DTBA1D1G on your CRT-D defibrillator. The lot/serial number BLF258300H indicates the recalled units. These devices were sold with the GTIN 00643169956650.
Identify the model number on your CRT-D defibrillator to see if it matches DTBA1D1G.
Check the lot/serial number on your device; if it is BLF258300H, it is part of the recall.
Medtronic recalls these CRT-D defibrillators due to a rare risk of reduced or no energy output during high voltage therapy, which could affect heart rhythm stability.
Check for the model number DTBA1D1G and lot/serial number BLF258300H on your device, which were sold with GTIN 00643169956650.
The recall record does not specify a remedy, so contact Medtronic directly for guidance.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1730-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1730-2023 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.