The Recall Desk
SevereFDA (Devices)·Z-1444-2021·Announced 2021-04-28

Biotronik Ilestro 7 VR-T Defibrillators Recalled for Battery Depletion Risk

Biotronik is recalling 323 Ilestro 7 VR-T defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a life-sustaining medical device (ICD/CRT-D) where premature battery depletion could result in significant injury or death if the device fails to treat life-threatening arrhythmias.

Plain-English summary

Biotronik Inc is recalling 323 units of the Ilestro 7 VR-T, DF-4 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The recall is issued because there is a potential for premature battery depletion in these devices. The affected units are identified by specific serial numbers listed in the recall notice and have a UDI of 04035479125363.

The affected devices are intended to provide ventricular tachycardia pacing and ventricular defibrillation for the automatic treatment of life-threatening ventricular arrhythmias. The recall covers units distributed nationwide in the United States and worldwide. The agency has classified this recall as Class II.

Patients with these implanted devices should contact their healthcare provider or Biotronik Inc to determine if their specific device is affected and to discuss appropriate monitoring or replacement options. The recall number is Z-1444-2021.

The recalled product

Product
BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Manufacturer
BIOTRONIK Inc
Category
Medical Device — Implantable Cardioverter Defibrillator
Hazard
Affected units
323

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 25 recalled by BIOTRONIK Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 25 products in this recall →

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