BIOTRONIK recalls specific ILIVIA 7 ProMRI defibrillators (serial numbers 60921641-61041652) due to potential premature battery depletion. This may cause device failure during critical cardiac events.
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 that may experience premature battery depletion. This could lead to device failure during life-threatening cardiac events, requiring immediate attention.
The defibrillator's battery may deplete prematurely, causing the device to stop working during critical cardiac events. This could prevent life-saving treatments for dangerous heart rhythms.
Patients with implanted cardiac devices like defibrillators who own the recalled model (serial numbers 60921641 to 61041652) are affected. Those with existing devices are at risk of malfunction during critical cardiac events.
Check if your device has the serial numbers listed in the recall (60921641 through 61041652). The product is an implantable defibrillator for heart rhythm management.
Your doctor or cardiac specialist should evaluate if your device is affected and provide guidance on next steps.
Check your device's serial number against the list of affected units provided in the recall notice.
If your device has a serial number between 60921641 and 61041652, it may experience premature battery depletion and could malfunction during critical cardiac events.
Contact your healthcare provider immediately to determine if your device is affected and to discuss next steps for evaluation or potential replacement.
Compare your device's serial number with the list of affected units (60921641 to 61041652) provided in the recall notice.
We’ve drafted a message you can send BIOTRONIK to request your refund or repair — edit it as you like.
Subject: Recall Z-1457-2021 — BIOTRONIK BIOTRONIK Hello, I own a BIOTRONIK that is covered by recall Z-1457-2021 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.
