Medical Device Recall: ORISE Gel Submucosal Lifting Agent Due to Foreign Body Reactions
Boston Scientific is recalling ORISE Gel Submucosal Lifting Agent due to higher incidence of foreign body reactions to retained gel. These reactions caused mass formations requiring surgical intervention.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II device with documented serious adverse events. Mass formations from retained gel required surgical intervention, meeting the rubric criterion for significant injury requiring medical intervention.
Plain-English summary
ORISE Gel Submucosal Lifting Agent, manufactured by Boston Scientific Corporation, is being recalled worldwide. The device is intended for gastrointestinal endoscopic procedures to lift polyps, adenomas, early-stage cancers, and other gastrointestinal lesions prior to removal.
The recall was initiated due to higher incidence of adverse events involving foreign body reactions to remnant gel remaining after the procedure. Retained ORISE Gel caused mass formations that required surgical intervention.
All batches of the product across all packaging configurations are affected. The recall involves 402,968 units distributed worldwide, including the United States and multiple foreign countries.
Patients and healthcare providers should discontinue use of ORISE Gel. Contact Boston Scientific for instructions regarding product return and alternative procedures.
The recalled product
- Product
- ORISE Gel Submucosal Lifting Agent--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 Packaged as
- Manufacturer
- Boston Scientific Corporation
- Hazard
- foreign-body-reaction
- retained-material
Distribution
Distributed nationwide across the United States.
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