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Orise proknife procedure and gel syringe kits
Official notice
26 Oct 2022
Last checked
26 Oct 2022
An official Health Canada notice concerns Orise proknife procedure and gel syringe kits. 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 Published 2022-10-26.
What to do now
Contact the manufacturer if you require additional information.
Recall number
72078
Official notice
2022-10-26
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
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Brand: Boston Scientific, Orise Proknife Procedure And Gel Syringe Kits.
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Source & status
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Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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