BIOTRONIK recalls IPERIA 7 Defibrillators with serial numbers 60826231-60999389 due to potential premature battery depletion. Affected devices may require replacement to prevent device failure.
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
BIOTRONIK is recalling its IPERIA 7 Defibrillator models (serial numbers 60826231 to 60999389) because they may experience premature battery depletion. This could lead to device failure and potential health risks for users.
The devices may deplete their batteries faster than expected, which could cause the device to stop functioning properly. This might lead to the device failing to treat life-threatening heart rhythms as intended.
Patients with implanted cardiac devices like defibrillators or pacemakers who own the recalled IPERIA 7 models are most at risk. The recall affects specific serial numbers listed in the official notice.
Check your device's serial number against the list of affected numbers (60826231 to 60999389) provided in the recall notice. The devices are intended for ventricular pacing and defibrillation.
Compare your device's serial number with the list of affected numbers (60826231 to 60999389) provided in the recall notice.
If your device is on the list, contact BIOTRONIK directly for instructions on device replacement or repair.
The recalled devices are BIOTRONIK IPERIA 7 Defibrillators with serial numbers from 60826231 to 60999389.
Check your device's serial number against the list of affected numbers (60826231 to 60999389) provided in the recall notice.
The recall does not require immediate replacement; contact BIOTRONIK for instructions on device replacement or repair if your device is on the list.
We’ve drafted a message you can send BIOTRONIK to request your refund or repair — edit it as you like.
Subject: Recall Z-1453-2021 — BIOTRONIK BIOTRONIK Hello, I own a BIOTRONIK that is covered by recall Z-1453-2021 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.
