Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Devices with Delivery System.
The manufacturer has received an increased number (6 of 207 - 2.9%) of implant embolization reports both during procedure (2) and post procedure (4) on the WATCHMAN FLX LAAC Devices.
For the WATCHMAN FLX LAAC devices that have been previously implanted, affected users should continue to follow patients in accordance with the Directions for Use, including specified follow-up Trans-Esophageal Echocardiographic (TEE) imaging.
This removal affects certain catalogue and lot numbers of the WATCHMAN FLX LAAC Device. Further distribution or implantation of the affected device should cease immediately.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 1 April 2016