Orise Gel Pack and Procedure Kit
Brand(s)
Last updated
Summary
Product
Orise Gel Pack and Procedure Kit
Issue
Medical devices - Performance issue
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Orise Gel Syringe Single Pack | All lots. | M00519231 M00519210 M00519220 M00519221 M00519230 M00519211 |
| Orise Gel Syringe Twin Pack | All lots. | M00519201 M00519200 |
| Orise Gel Twin Syringe Kit With Interject | All lots. | Not applicable |
| Orise Proknife Procedure Kit | All lots. | M00519400 M00519380 M00519390 |
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Ear, nose and throat
Health products - Medical devices - General and plastic surgery
Health products - Medical devices - General hospital and personal use
Companies
Boston Scientific Corporation
300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72503
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