BIOTRONIK recalls ILIVIA 7 ProMRI defibrillators with potential premature battery depletion. Affected units have specific serial numbers; contact for replacement or repair.
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
BIOTRONIK is recalling certain ILIVIA 7 ProMRI defibrillators due to a risk of premature battery depletion. This could cause the device to stop working properly, potentially leading to life-threatening arrhythmias if the device fails during critical medical situations.
The device may deplete its battery faster than intended, which could cause it to stop working when needed. This risk is highest during critical medical events where the device must function to treat life-threatening heart rhythms.
Patients with implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) using the recalled models are affected. Those with the specific serial numbers listed in the recall are most at risk.
Check the serial numbers listed in the recall (e.g., 60921514, 60921555, etc.) on the device's label. The product is intended for ventricular tachycardia pacing and defibrillation for life-threatening arrhythmias.
Look for the serial number on the device label to confirm if it's in the list of affected units.
Reach out to BIOTRONIK directly for instructions on replacement or repair options.
The device may have a risk of premature battery depletion, which could cause it to stop working during critical medical events. It is not safe to use without checking the recall.
Check the serial number against the list provided in the recall. If affected, contact BIOTRONIK for replacement or repair instructions.
The affected devices have specific serial numbers listed in the recall. Check the label on your device for the serial number and compare it to the provided list.
We’ve drafted a message you can send BIOTRONIK to request your refund or repair — edit it as you like.
Subject: Recall Z-1458-2021 — BIOTRONIK BIOTRONIK Hello, I own a BIOTRONIK that is covered by recall Z-1458-2021 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.
