The Recall Desk
HighFDA (Devices)·Z-1452-2021·Announced 2021-04-28

Biotronik ITREVIA 7 Defibrillators Recalled for Premature Battery Depletion

Biotronik is recalling 670 ITREVIA 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (life-saving defibrillator) where the hazard is premature battery depletion, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Biotronik Inc is recalling 670 units of the ITREVIA 7, VR-T DF-4 implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D). The recall is due to a potential for premature battery depletion in these devices. The affected units are identified by specific serial numbers listed in the recall notice.

The 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 classification for this recall is Class II.

Patients with these devices should contact their healthcare provider or Biotronik Inc to determine if their specific device is affected and to discuss appropriate management options. The recall number is Z-1452-2021.

The recalled product

Product
BIOTRONIK ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - 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
670

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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