Important Safety Alerts

The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit. The affected devices are identified as follow:-

• Model: 1) HVAD Pump Driveline Splice Kit; 2) HVAD Pump Driveline Splicekit; Large OD Sheath
• Catalogue numbers: 1) ASY00116; 2) ASY00281
• Lot numbers: 1) 532770, 567949, 480786, 483769, 490692, 539664, 598189; 2) 654090, 672401, 678800, 690423, 833963, 873159, 880816

According to the manufacturer, excessive force applied will cause failures of the splice repair kit.

According to the local supplier, the affected products are not distributed in Hong Kong.

For details, please refer to the FDA website:

http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1604-2015&w=05202015&lang=eng

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

Posted on 21 May 2015