Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its TRAPPER Exchange Device. [UPN #: H74939330130, GTIN: 05391526210154; Lot/Batch #: 3571027063, 3571027064, 3571027089, 3571027334, 3571027335, 3571027559, 3571027680, 3571027830, 3571028073 - with Expiration Date Range between October 12, 2022 and February 3, 2023]
The manufacturer is initiating a removal of certain lots/batches of the TRAPPER Exchange Devices due to an increase in complaints of difficulty or failure to inflate the balloon at the distal tip of the device. These events were caused by a weakened bond between the manifold and the lumen. There have been no reports of patient injury to date.
The manufacturer request users to verify whether any product within their inventory is affected. Further distribution or use of any remaining affected product should cease immediately. If users identify any product from the affected lots/batches within their inventory, please segregate the product immediately 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 9 June 2021