Important Safety Alerts

Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its WATCHMAN left atrial appendage closure device. The affected products are as follows:-

• WATCHMAN Left Atrial Appendage (LAA) Closure Device with Delivery System
  • [Material Number: M635WC21060, M635WC24060, M635WC27060, M635WC30060, M635WC33060, M635WS21060, M635WS24060, M635WS27060, M635WS30060, M635WS33060, M635WU21060, M635WU24060, M635WU27060, M635WU30060, M635WU33060]
• WATCHMAN Access System (Access Sheath with Dilator)
  • [Material Number: M635TC10060, M635TC20060, M635TS10060, M635TS20060, M635TS40060, M635TU10060, M635TU20060, M635TU40060]

The manufacturer has determined that cross-threading of the haemostasis valve may occur if the valve is tightened with the dilator in place, potentially preventing subsequently sealing of the valve when desired.

The manufacturer has updated the Directions for Use (DFU) to clarify the correct use of the haemostasis valve and interaction between the access sheath and dilator. There is no product being recalled and no impact to previously implanted devices.

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

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

Posted on 28 August 2015