# FDA recall Z-1444-2021

> **BIOTRONIK Inc** · Class II · device recall initiated 2021-03-08.

## 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.

## Reason for recall

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

## Distribution

US: Nationwide  OUS: Worldwide

## Key facts

- **Recall number:** Z-1444-2021
- **Recalling firm:** BIOTRONIK Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-08
- **Report date:** 2021-04-28
- **Termination date:** 2023-04-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Oswego, OR, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1444-2021

## Citation

> AI Analytics. FDA recall Z-1444-2021. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1444-2021. Source: US FDA. Licensed CC0.

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