# FDA recall Z-0508-2026

> **Thoratec LLC** · Class II · device recall initiated 2025-10-09.

## Product

Brand Name: HeartMate  Product Name: HeartMate II¿ Controller (standalone)  Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US; 106762, HeartMate II¿ Pocket Controller, US; 107801, HeartMate II¿ Pocket Controller  Software Version: N/A  Product Description: The HeartMate II System Controller is a small computer that controls and monitors system  operation. It sends power and operating signals to the Left Ventricular Assist Device and  adjusts device operation to maintain programmed levels of cardiac support. The System  Controller identifies alarm conditions and initiates Hazard and Advisory alarms. It records  device performance and alarm data, and transfers the information to the HeartMate Touch  Communication System.  Component: Yes, HeartMate II¿ LVAS Implant Kit

## Reason for recall

Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

## Distribution

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of Algeria, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Macedonia, Malaysia, Martinique, Montenegro, Morocco, Netherlands, New Zealand, Norway, Oman, Palestine, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UK, United Arab Emirates, Uzbekistan.

## Key facts

- **Recall number:** Z-0508-2026
- **Recalling firm:** Thoratec LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-09
- **Report date:** 2025-11-26

- **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-0508-2026

## Citation

> AI Analytics. FDA recall Z-0508-2026. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-0508-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*