Orise Gel Pack and Procedure Kit
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Orise Gel Syringe Single Pack |
All lots. |
M00519231 |
Orise Gel Syringe Twin Pack |
All lots. |
M00519201 |
Orise Gel Twin Syringe Kit With Interject |
All lots. |
Not applicable |
Orise Proknife Procedure Kit |
All lots. |
M00519400 |
Issue
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
Additional information
Details
Boston Scientific Corporation
300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752