Boston Scientific (BSC) initiated a field action in October 2022, communicating that remnant orise gel post-procedure can cause a foreign body reaction, appearing as mass formations and submucosal distortions. Since this time, BSC has become aware of additional events leading to unnecessary medical and surgical intervention. As a result, BSC now believes the occurrence is potentially higher than anticipated, therefore, this product is being removed from the market. Recall start date: December 15, 2022
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