Item 8.01 Other Events

On February 7, 2013, HeartWare initiated a voluntary field correction advising healthcare professionals to inspect the driveline connector housing of the HVADŽ Pump during routine clinic visits. A small number of events (11 of approximately 2900 implants) have been confirmed where the rear portion of the HVAD Pump's driveline connector housing becomes partially or fully separated from the front portion of the driveline connector after extended use. In the unlikely event of a separation, a repair may be necessary. If left unattended, electrical connection to the controller could be affected and a VAD stop alarm could result. None of the confirmed events have resulted in harm to the patient.

In the event of a separation, hand tightening of the connector housing may be sufficient as a temporary measure; however, healthcare professionals are instructed to contact HeartWare to arrange for an inspection and permanent repair by a HeartWare Clinical Engineer. No product replacement or exchange is required.

As indicated in the Instructions for Use (IFU) and Patient Manual, patients should not pull, kink or twist the driveline or the power cables, as these actions may damage the driveline.

Manufacturing process changes designed to prevent recurrence of this event are being implemented. The field correction is not expected to have a significant impact on the Company's financial position.

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