BIOTRONIK recalls Ilestro 7 DR-T and DF-1 devices with specific serial numbers due to potential premature battery depletion. This could affect implantable cardioverter defibrillators and cardiac resynchronization therapy devices. Affected units include 60+ serial numbers listed in the recall.
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
BIOTRONIK is recalling certain Ilestro 7 DR-T and DF-1 implantable defibrillators because they may deplete their batteries prematurely. This could cause the device to stop working properly and fail to treat life-threatening heart rhythms. The recall includes specific serial numbers listed in the official notice.
The recalled devices have a potential for premature battery depletion, meaning the battery may drain faster than expected. This could cause the device to stop functioning properly and fail to treat life-threatening heart rhythms, though the risk is low and the devices are designed to last many years.
Patients with implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) who own the recalled devices are affected. The risk is low because the devices are designed to be long-lasting and the issue is limited to specific units.
Check if your device has the serial numbers listed in the recall notice (60+ specific numbers provided). The product is an implantable defibrillator used for heart rhythm management.
Compare your device's serial number with the list of affected serial numbers provided in the recall notice.
If your device is listed, contact BIOTRONIK directly for further instructions.
BIOTRONIK has identified a potential for premature battery depletion in certain Ilestro 7 DR-T and DF-1 devices, which could cause the device to stop working properly.
If your device's serial number is not on the list, it is not affected by this recall and no action is required.
The recall includes 60+ specific serial numbers listed in the official notice.
We’ve drafted a message you can send BIOTRONIK to request your refund or repair — edit it as you like.
Subject: Recall Z-1441-2021 — BIOTRONIK BIOTRONIK Hello, I own a BIOTRONIK that is covered by recall Z-1441-2021 from BIOTRONIK. 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.
