The United States Food and Drug Administration (FDA) has issued medical device safety alerts concerning HeartWare Ventricular Assist System (VAS), manufactured by HeartWare. The affected devices are identified as follow:-

• Product Codes: 1101, 1103
• Serial Numbers: All Heartware systems currently in use
• Manufacturing and Distribution Dates: January 2008 to March 2015

The alignment guides in the power supply connector ports may wear down over time. This can cause the connection pins to become twisted or bent, and eventually prevent the patient from connecting the device controller to their VAS. An interruption in this electrical connection would cause the pump to stop, which could cause serious patient injury or death. The company has reported 33 reports of malfunction and one serious injury related to this problem.

The manufacturer sent their customers an Urgent Medical Device Correction notice on May 25, 2015 to alert them of the problem and actions to take. The manufacturer will replace all defective controllers by the end of June 2016.

The manufacturer is reminding patients to use the device safely:

• Never disconnect from both power sources at the same time.
• Take care when connecting to power sources.
• Keep the outer sheath of the driveline protected from excessive sunlight.
• Beware of accidental snagging or pulling of the driveline.

According to the local supplier, the affected products are distributed in Hong Kong.

For details, please refer to the FDA websites:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm451456.htmhttp://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm451447.htm

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 17 June 2015