Important Safety Alerts

Medical device manufacturer, Boston Scientific Corporation, has issued a medical device safety alert concerning the following products:

• Product UPN: H749LVS230, H749LVS250, H749LVS270, H749LVSUS230, H749LVSUS250, H749LVSUS270, H749LVSCL230, H749LVSCL250, H749LVSCL270
• Product GTIN: 08714729940814, 08714729940821, 08714729940838, 08714729960904, 08714729960911, 08714729960928, 08714729905592, 08714729905608, 08714729905615
• Lot Number : All lot numbers
• Expiration Date Range: All non- expired inventory

The manufacturer is voluntarily implementing a removal of the unused inventory of the LOTUS Edge Valve System. Further distribution or use of any remaining unused affected products from the affected lots/batches should cease immediately.

According to the manufacturer, there is no safety issue for patients who have previously received LOTUS Edge valve and the valve continues to show acceptable clinical performance post-implant.

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

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

Posted on 19 November 2020