BIOTRONIK recalls specific ITREVIA 7 defibrillators due to potential premature battery depletion. Affected units have serial numbers listed in the recall notice. 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 that may experience premature battery depletion. This could lead to the device failing to function properly when needed, potentially causing serious health risks for users.
The recalled devices have a potential for premature battery depletion, meaning the battery may drain faster than expected. This could cause the device to stop working when it's needed to treat life-threatening heart rhythms.
Individuals with the recalled ITREVIA 7 defibrillators (serial numbers listed in the recall) are most at risk. These devices are used for life-threatening heart conditions and require reliable operation.
Check if your device has a serial number starting with '608' or '609' (e.g., 60819315, 60900316). The device is intended for ventricular pacing and defibrillation in patients with serious heart conditions.
Look for the serial number on your device, which starts with '608' or '609' (e.g., 60819315, 60900316).
Reach out to BIOTRONIK directly for further instructions on how to address the issue.
BIOTRONIK recalls these specific ITREVIA 7 defibrillators due to a potential risk of premature battery depletion, which could cause the device to fail when needed.
BIOTRONIK does not specify an immediate replacement; they recommend checking the serial number and contacting them for further instructions.
Check your device's serial number to see if it's listed in the recall. If it is, contact BIOTRONIK for guidance on next steps.
We’ve drafted a message you can send BIOTRONIK to request your refund or repair — edit it as you like.
Subject: Recall Z-1455-2021 — BIOTRONIK BIOTRONIK Hello, I own a BIOTRONIK that is covered by recall Z-1455-2021 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.
