BIOTRONIK recalls ITREVIA 7 defibrillators with potential premature battery depletion. Affected units have specific serial numbers; contact BIOTRONIK for details.
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
BIOTRONIK is recalling certain ITREVIA 7 defibrillators due to a potential risk of premature battery depletion. This could lead to the device failing to function properly when needed.
The device may deplete its battery faster than expected, potentially causing it to stop working during a medical emergency. However, this is a rare occurrence and the device is designed to function safely under normal conditions.
People with implanted ITREVIA 7 defibrillators (specific serial numbers listed) who require life-saving cardiac monitoring. The risk is low for most users as the device is designed to be safe.
Check if your device has the serial numbers listed in the recall notice (e.g., 60797220, 60800603, etc.). The product is an implantable defibrillator used for life-threatening heart rhythms.
Reach out to BIOTRONIK directly using the provided contact information to confirm if your device is affected and get instructions.
The recall specifically lists certain serial numbers. Check your device's serial number against the provided list to determine if it is affected.
Contact BIOTRONIK directly to confirm your device's status and receive further instructions.
Compare your device's serial number with the list of affected serial numbers 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-1451-2021 — BIOTRONIK BIOTRONIK Hello, I own a BIOTRONIK that is covered by recall Z-1451-2021 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.
