ORISE Gel Syringe Recall Due to Foreign Body Reaction Risk
Boston Scientific has recalled ORISE Gel Syringe kits used in gastrointestinal endoscopy due to higher incidence of foreign body reactions from remnant gel requiring surgical intervention.
- Product
- ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device
- Category
- Medical Device
- Distribution
- Distributed nationwide