Heartware Ventricular Assist System Controller Recall for Loose Connector Ports

Plain-English summary

Heartware, Inc. is recalling the HeartWare Ventricular Assist System Controller because of loose connector ports in the controller body. The device is used as a bridge-to-cardiac transplantation for patients at risk of death from refractory end-stage left ventricular heart failure.

The recall covers 4,235 units worldwide, with 7,272 units in the United States. Distribution includes the U.S. and several international countries. The affected units are all Heartware Controllers manufactured after September 2014, including specific U.S. and international model numbers.

Patients and healthcare providers should contact Heartware, Inc. for instructions on how to address the defect. The source text does not specify a particular action for consumers beyond the recall notice.

The recalled product

Product

HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD is designed for in-hospital and out-of-hospital settings, incl

Manufacturer

Heartware, Inc.

Category

Medical Device — Cardiac Device

Hazard

• loose-connector

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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