BIOTRONIK recalls Iforia 7 devices with specific serial numbers due to potential premature battery depletion in implantable defibrillators.
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
BIOTRONIK is recalling certain Iforia 7 devices that may experience premature battery depletion. This could lead to the device failing to function properly when needed, which is critical for patients with heart conditions.
The device may run out of battery before the intended lifespan, causing it to stop working when needed to treat life-threatening heart rhythms. This could lead to a failure in the device's ability to provide critical cardiac support.
Patients with implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) who own the recalled Iforia 7 models are affected. Those with these devices are at risk if the battery depletes prematurely.
Check the serial numbers listed in the recall notice (e.g., 60717860, 60722974, etc.) on your device's label. The product is intended for ventricular pacing and defibrillation in heart conditions.
Look for the serial number on your device's label to confirm if it's in the list of recalled units.
Reach out to BIOTRONIK directly for guidance on next steps if your device is affected.
BIOTRONIK recalls these devices due to a potential risk of premature battery depletion, which could cause the device to stop working when needed for life-threatening heart conditions.
Check the serial number on your device's label against the list of numbers provided in the recall notice (e.g., 60717860, 60722974, etc.).
Contact BIOTRONIK directly for guidance on next steps; they will provide instructions for device evaluation or replacement.
We’ve drafted a message you can send BIOTRONIK to request your refund or repair — edit it as you like.
Subject: Recall Z-1448-2021 — BIOTRONIK BIOTRONIK Hello, I own a BIOTRONIK that is covered by recall Z-1448-2021 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.
