Boston Scientific recently became aware of events associated with foreign body reaction which presented as mass formations from remnant Orise gel post procedure, prompting unnecessary surgical intervention at a rate of 0.0019% of units sold (based on known events and total sales to date). There have been no reported deaths associated with these events. As a result of these events, updates will be made to the product IFUs. The purpose of the updates is to (a) raise awareness that remnant Orise gel may elicit a foreign body reaction with granuloma and multinucleate giant cells that can physically appear as mass formations and submucosal distortions, (b) provide new warnings and precautions, and (c) reinforce the existing procedural instructions and the need to document the use of Orise gel during the procedure. Boston scientific is not removing any Orise gel devices from the field; devices remain available for use. Recall start date: October 11, 2022
RecallTracker