Thoratec LLC 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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

On 6/25/24, verbal and email communications were initiated informing customers of the following: 1) Carefully inspect the controller at the edge near the display button to confirm the UI membrane is not lifted (refer to provided visual examples). 2) Report Controllers with lifted UI membrane by contacting Firm's Technical Support at 1-800-456-1477. 3) Reinforce requirement as listed on Page 2-11 "System Controller Warnings and Cautions" in the IFU to patients to protect controller from water. Advise them to follow instructions to avoid direct exposure to water; and communicate risk of continuous, steady exposure to water. 4) Reinforce requirement to patient to perform the daily self-test to verify the display works appropriately as listed on Page 2-29 "Performing a System Controller Self Test". Patients should contact the hospital in the event of display issues. Firm will follow-up with a formal notification about the lifted UI membrane.

Distribution

As reported by FDA

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