BIOTRONIK recalls ILIVIA 7 devices due to potential premature battery depletion in implantable defibrillators. Affected units have specific serial numbers listed in the recall notice.
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
BIOTRONIK is recalling its ILIVIA 7 implantable defibrillator models due to a potential risk of premature battery depletion. This could lead to device failure and require replacement. Affected units have specific serial numbers listed in the recall notice.
The recall addresses a potential risk of premature battery depletion in these implantable defibrillators. If the battery depletes too quickly, the device may stop functioning properly, which could lead to life-threatening arrhythmias if the device fails to deliver necessary shocks.
Individuals with BIOTRONIK ILIVIA 7 implantable defibrillators (specifically models DR-T DF-1 PROMRI, REF 404622) and those who have the listed serial numbers are affected. Patients with these devices are at risk of device failure due to battery depletion.
Check if your device has the serial numbers listed in the recall notice (e.g., 61009745, 61031041, etc.). The product is intended for ventricular tachycardia pacing and defibrillation for life-threatening arrhythmias.
Verify if your device has a serial number listed in the recall notice (e.g., 61009745, 61031041, etc.).
Contact BIOTRONIK directly for further instructions on device replacement or repair.
The recall indicates a potential risk of premature battery depletion in these specific models. Check your device's serial number against the list provided in the recall notice.
Contact BIOTRONIK directly for instructions on device replacement or repair. The recall does not specify an immediate action beyond checking the serial number.
Check your device's serial number against the list of affected serial numbers provided in the recall notice (e.g., 61009745, 61031041, etc.).
We’ve drafted a message you can send BIOTRONIK to request your refund or repair — edit it as you like.
Subject: Recall Z-1461-2021 — BIOTRONIK BIOTRONIK Hello, I own a BIOTRONIK that is covered by recall Z-1461-2021 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.
