Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Upsylon Y Mesh Kit with Colpassist Vaginal Positioning Device [UPN: M0068318220, GTIN: 08714729848103, Multiple Lots] & Colpassist Vaginal Positioning Device [UPN: M0068318210,GTIN: 08714729848097, Multiple Lots].
The manufacturer is conducting a voluntary removal of all unexpired lots of the Colpassist Vaginal Positioning Device. According to the manufacturer, its internal testing revealed the potential for pinholes on the edge of the pouch of the device, which may potentially render the device non-sterile. The most serious health risk includes post-operative vaginal infection of moderate severity.
Users should stop using any product of the affected lots/batches within their inventory, and return it to the manufacturer.
According to the local supplier, the products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary action.
Posted on 16 April 2021