Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
HeartMate 3 System Controllers provided within the following HeartMate 3 Recalled by Thoratec LLC Due to Left ventricular assist system controller UI membrane/screen may...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Thoratec LLC directly.
Affected Products
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
Quantity: 694
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed to 42 states: AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI, DC
About Thoratec LLC
Thoratec LLC has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report