# FDA recall Z-2583-2024

> **Thoratec LLC** · Class II · device recall initiated 2024-06-25.

## Product

HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed separately:     HeartMate 3 LVAS Implant Kit, US, Model: 106524US;  HeartMate 3 LVAS Implant Kit, OUS, Model: 106524INT;  HeartMate 3 System Controller, US, Model: 106531US;  HeartMate 3 System Controller, OUS, Model: 106531INT;  HeartMate 3 System Controller Low Flow 2.0, Global, Model: 106531LF2

## Reason for recall

Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress may occur, which may damage printed circuit board assemblies, which could result in unexpected and false positive alarms, loss of visual alarms, loss of user interface(use of buttons, loss of visual alarms,etc.), loss of power, and pump stop

## Distribution

US: MN, PA, FL, IL, NY, DE, AR, NJ, NC, GA, WI, AZ, TN, MO, TX, MA, OH, VA, NE, CA, OK, CO, DC, IN, MI, CT, UT, IA, MD, OR, NM, ME, SC, KY, LA, WA, NV, HI, AL, MS, KS, WV.  OUS: Algeria, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Korea, Kuwait, Lebanon, Lithuania, Macedonia, Morocco, Netherlands, New Zealand, Norway, Oman, Palestine, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan

## Key facts

- **Recall number:** Z-2583-2024
- **Recalling firm:** Thoratec LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-25
- **Report date:** 2024-08-21

- **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-2583-2024

## Citation

> AI Analytics. FDA recall Z-2583-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2583-2024. Source: US FDA. Licensed CC0.

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