BIOTRONIK recalls specific INVENTRA 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 INVENTRA 7 defibrillators that may experience premature battery depletion. This could lead to the device failing to function properly when needed. Affected units have specific serial numbers listed in the recall notice.
The recalled devices may deplete their battery prematurely, which could cause the device to stop working when needed to treat life-threatening heart rhythms. This is a potential risk for patients relying on the device for critical heart function.
Patients with implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) who own the recalled devices are most at risk. The recall affects specific serial numbers listed in the notice.
Check if your device has the serial numbers listed in the recall notice (e.g., 60841286, 60869296, etc.). The product is an implantable defibrillator used for heart rhythm treatment.
Look for the serial number on your device's label to see if it matches the list of affected numbers provided in the recall notice.
BIOTRONIK recalls specific INVENTRA 7 defibrillators due to a potential risk of premature battery depletion, which could cause the device to stop working when needed.
The recall does not require replacement; affected devices should be checked by a healthcare provider to determine if action is needed.
Check your device's serial number against the list of affected 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-1454-2021 — BIOTRONIK BIOTRONIK Hello, I own a BIOTRONIK that is covered by recall Z-1454-2021 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.
