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, posing a risk to patients with heart conditions.
The device may deplete its battery faster than expected, potentially causing it to stop working when needed to treat life-threatening heart rhythms. This could lead to the device failing during an emergency situation.
Patients with implanted cardiac devices like defibrillators or cardiac resynchronization therapy devices. Those with the specific serial numbers listed in the recall are most at risk.
Check if your device is listed in the serial numbers provided in the recall notice. The product is an implantable defibrillator used for heart rhythm treatment.
Compare your device's serial number to the list of affected numbers provided in the recall notice.
BIOTRONIK recalls specific ITREVIA 7 defibrillators due to a potential risk of premature battery depletion, which could cause the device to fail during emergencies.
Check your device's serial number against the list of affected numbers provided in the recall notice.
Contact BIOTRONIK directly for further instructions on how to address the issue.
We’ve drafted a message you can send BIOTRONIK to request your refund or repair — edit it as you like.
Subject: Recall Z-1450-2021 — BIOTRONIK BIOTRONIK Hello, I own a BIOTRONIK that is covered by recall Z-1450-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
