HeartMate 3 Mobile Power Unit — Class II medical device recall Z-0746-2020
Terminated recall by Thoratec Corp., reported 2020-01-08, distributed nationwide. Excessive static electricity can potentially cause unrecoverable power loss and damage to the mobile power uni
| Recall number | Z-0746-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thoratec Corp., Pleasanton, CA, United States |
| Recall initiated | 2019-12-02 |
| Classified | 2019-12-27 |
| Reported by FDA | 2020-01-08 |
| Terminated | 2022-09-14 |
| Distributed | Nationwide (US) |
| Quantity | 13,871 |
| UPC / GTIN / UDI-DI | 00813024010883, 00813024010890, 00813024011712, 00813024013297 |
| Model numbers | 106524US, 107754 |
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 for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.