BIOTRONIK recalls Ilestro 7 VR-T defibrillators with serial numbers starting 60713356-60803564 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 certain Ilestro 7 VR-T defibrillators because they may run out of battery too soon, which could cause the device to stop working during a life-threatening heart rhythm event. This is a serious risk for patients using these devices.
The defibrillator may deplete its battery prematurely, which could cause the device to stop functioning during a critical heart rhythm event. This might prevent the device from delivering necessary shocks to save a patient's life.
Patients with implanted Ilestro 7 VR-T defibrillators (specifically those with serial numbers listed in the recall) are most at risk. These devices are used to treat life-threatening heart arrhythmias.
Check your device's serial number against the list of affected units provided in the recall notice. The affected models are BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578 with UDI: 04035479125349.
Compare your device's serial number with the list of affected units provided in the recall notice.
Reach out to BIOTRONIK directly for guidance on next steps if your device is affected.
If your device has a serial number listed in the provided recall list (e.g., 60713356-60803564), it is affected by this recall.
Contact BIOTRONIK directly for guidance on next steps. They will provide instructions for device evaluation or replacement.
Yes, premature battery depletion could cause the device to stop functioning during a critical heart rhythm event, potentially preventing life-saving shocks.
We’ve drafted a message you can send BIOTRONIK to request your refund or repair — edit it as you like.
Subject: Recall Z-1443-2021 — BIOTRONIK BIOTRONIK Hello, I own a BIOTRONIK that is covered by recall Z-1443-2021 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.
