HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, an ...



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.
Components:
Units Affected:    13,871
Recall Date:    Dec 2, 2019
Mfg:
Thoratec Corp.
Mfg Country:
United States
Recall ID:    84379
Product ID:    178196
Enforcement Date:    Jan 8, 2020
Last Published:    Dec 27, 2019

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Emert Number:    Z-0746-2020
Emert Status:    Announced