Recall Z-2583-2024— Thoratec LLC

Class II FDA medical device recall by Thoratec LLC, initiated 2024-06-25. FDA's recall record names no specific 510(k) clearance for this event. 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: 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.

Recalling firm

Thoratec LLC

Classification

Class II

Status

Ongoing

Initiated

2024-06-25

Firm location

Pleasanton, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.