BIOTRONIK recalls specific INVENTRA 7 defibrillators due to potential premature battery depletion. Affected units have unique serial numbers listed in the recall notice.
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 device failure during critical heart rhythm treatments.
The defibrillators may deplete their batteries faster than expected, potentially causing the device to stop working during a life-threatening heart rhythm event. This could lead to treatment failure if the device is needed.
People with implanted defibrillators using the recalled models are affected. Those with the specific serial numbers listed in the recall are most at risk.
Check if your device has the serial numbers listed in the recall notice (60781273 through 60839098). The product is an implantable defibrillator 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.
No action is needed if your device's serial number is not listed in the recall notice.
Check the serial number on your device against the list of numbers provided in the recall notice.
The recall notice does not mention any remedy or fix for this issue.
We’ve drafted a message you can send BIOTRONIK to request your refund or repair — edit it as you like.
Subject: Recall Z-1460-2021 — BIOTRONIK BIOTRONIK Hello, I own a BIOTRONIK that is covered by recall Z-1460-2021 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.
