Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0746-2020 — 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

U.S. FDA — Device Enforcement · United States · 2019-12-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0746-2020
Date of alert: 2019-12-02
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Thoratec Corp.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00813024010883

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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