Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

BIOTRONIK ITREVIA 7 Recalled by BIOTRONIK Inc Due to There is a potential for premature battery depletion...

Date: March 8, 2021
Company: BIOTRONIK Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact BIOTRONIK Inc directly.

Affected Products

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.

Quantity: 670 units

Why Was This Recalled?

There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About BIOTRONIK Inc

BIOTRONIK Inc has 25 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report