# FDA recall Z-2520-2026

> **Thoratec LLC** · Class II · device recall initiated 2026-05-13.

## Product

Brand Name: HeartMate  Product Name: HM 11V Li-ion Backup Battery, ABT  Model/Catalog Number: 106128  Software Version: N/A  Product Description: The HeartMate 11 Volt Lithium Ion Standalone Backup Battery is a component of the HeartMate 3" System Controller and provides power to the System Controller. The HeartMate System Controller is an external device that manages the HeartMate Left Ventricular Assist System (LVAS), including alarms, system monitoring, and communication. It contains an internal 11V lithium-ion backup battery that provides at least 15 minutes of emergency power should the main system power source fail. The backup battery must be properly installed, charges automatically during normal use, and has a 36-month service life from date of manufacture.  Component: Yes, HeartMate 3" System Controller

## Reason for recall

Due to 11 volt Backup Battery failures.

## Distribution

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Canada, Germany, Japan, Netherlands, Poland, Spain.

## Key facts

- **Recall number:** Z-2520-2026
- **Recalling firm:** Thoratec LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-05-13
- **Report date:** 2026-06-24

- **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-2520-2026

## Citation

> MORVS. FDA recall Z-2520-2026. Retrieved 2026-10-19 from https://api.morvs.ai/recall/Z-2520-2026. Source: US FDA. Licensed CC0.

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