BIOTRONIK recalls ITREVIA 7 defibrillators with serial numbers starting 60758873 to 60921113 due to potential premature battery depletion. This may cause device failure during critical heart rhythm treatments.
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
BIOTRONIK is recalling its ITREVIA 7 defibrillator models because they may run out of battery too soon, which could cause the device to stop working during a life-threatening heart rhythm emergency. This is serious because the device is used to treat dangerous heart arrhythmias.
The defibrillator may deplete its battery prematurely, causing it to stop working when needed. This could happen during a life-threatening heart rhythm event, where the device is critical for automatic treatment.
People with a BIOTRONIK ITREVIA 7 defibrillator (serial numbers 60758873 to 60921113) who are at risk of heart arrhythmias. Patients with these devices are most vulnerable to device failure during emergencies.
Check your defibrillator's serial number on the device or packaging. The recalled models have serial numbers starting with 60758873 and ending with 60921113.
Look for the serial number on your defibrillator or its packaging to confirm if it's in the recalled range (60758873 to 60921113).
Reach out to BIOTRONIK directly to confirm your device's status and get instructions on next steps.
BIOTRONIK recalls these devices because they may run out of battery too soon, which could cause the device to stop working during a life-threatening heart rhythm emergency.
No, but you should check your serial number and contact BIOTRONIK for guidance. The recall does not require immediate discontinuation of use.
Check your serial number to see if it's in the recalled range (60758873 to 60921113), then contact BIOTRONIK for specific instructions.
We’ve drafted a message you can send BIOTRONIK to request your refund or repair — edit it as you like.
Subject: Recall Z-1452-2021 — BIOTRONIK BIOTRONIK Hello, I own a BIOTRONIK that is covered by recall Z-1452-2021 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.
