# FDA recall Z-0842-2024

> **Thoratec Corp.** · Class I · device recall initiated 2024-01-03.

## Product

1. HeartMate Touch Communication System, REF HMT1100  2. HeartMate Touch Communication System, Rental REF HMT1100-R  3. HeartMate Touch Communication System, HMT1150    The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art hardware/software platforms for supporting LVAD patients. Along with being able to program and monitor the LVAS, the HeartMate Touch Application introduces features that enables users to setup pairing and connection with the existing HeartMate 3 Left Ventricular Assist System (LVAS) via the HeartMate Touch Wireless Adapter and generate reports from the log files that are downloaded from the HM3 System Controller.

## Reason for recall

Due to software and controller systems that results in unexpected pump start or pump stop.

## Distribution

Worldwide distribution.  US nationwide, Australia, Austria, Canada, Colombia, Czech Republic, Germany, Hong Kong, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Martinique, New Zealand, Poland, Romania, Saudi Arabia, Singapore, Spain, Switzerland, Thailand and United Arab Emirates.

## Key facts

- **Recall number:** Z-0842-2024
- **Recalling firm:** Thoratec Corp.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-03
- **Report date:** 2024-02-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pleasanton, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0842-2024

## Citation

> AI Analytics. FDA recall Z-0842-2024. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-0842-2024. Source: US FDA. Licensed CC0.

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