# FDA recall Z-1993-2023

> **Heartware, Inc.** · Class II · device recall initiated 2023-05-16.

## Product

HeartWare Ventricular Assist Device System.   a) Monitor 1521US Explore Tech,  b) Monitor 1521GB Explore Tech,  c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech

## Reason for recall

Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON4xxxxxx for OUS and MON5xxxxxx for US), are unable to be processed by the Autologs web portal.

## Distribution

Worldwide - US Nationwide distribution in the states of TX, MO, VA, and the countries of Bahrain, UK.

## Key facts

- **Recall number:** Z-1993-2023
- **Recalling firm:** Heartware, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-16
- **Report date:** 2023-06-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Miami Lakes, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1993-2023

## Citation

> AI Analytics. FDA recall Z-1993-2023. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-1993-2023. Source: US FDA. Licensed CC0.

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