Recall Z-0746-2020— Thoratec Corp.

Class II FDA medical device recall by Thoratec Corp., initiated 2019-12-02, terminated 2022-09-14. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the HeartMate 3 Left Ventricular Assist System, REF 106524US, UDI or GTIN: 00813024013297, and 106524, UDI or GTIN: 00813024011712 - Product Usage: Provides power to the System Controller and pump. - Provides power to the System Monitor when it is connected to the Power Module. - Connects the System Monitor to the System Controller for monitoring purposes. - Echoes System Controller alarms. The Mobile Power Unit is for home or clinical use when the patient does not require monitoring using the System Monitor. The Mobile Power Unit is used when the patient is indoors, stationary, or sleeping. The System Controller and the Mobile Power Unit are connected through the Mobile Power Unit patient cable. The cable transfers power from the Mobile Power Unit to the System Controller.. Reason: Excessive static electricity can potentially cause unrecoverable power loss and damage to the mobile power unit that can be used to power the left ventricular assist system, which could lead to no or reduced blood flow from the left ventricular assist system..

Recalling firm

Thoratec Corp.

Classification

Class II

Status

Terminated

Initiated

2019-12-02

Terminated

2022-09-14

Firm location

Pleasanton, CA, United States

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