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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is FDA Class II with reported adverse events of foreign body reactions requiring surgical intervention, which constitutes significant injury requiring medical intervention.
Plain-English summary
Boston Scientific Corporation is recalling ORISE Gel Syringe Submucosal Lifting Agent Kits used in gastrointestinal endoscopic procedures. The kits are designed to lift the submucosa of polyps, adenomas, early-stage cancers, and other gastrointestinal lesions prior to excision with an endoscopic device.
The recall was initiated due to a higher incidence of adverse events involving foreign body reactions to remnant ORISE Gel that remained in the tissue after the procedure. These reactions presented as mass formations from the remnant gel, which in affected cases required surgical intervention.
A total of 402,968 units have been distributed worldwide, including throughout the United States and internationally to countries in Europe, Asia, the Middle East, Africa, South America, and the Pacific region. All batches of the product are affected by this recall.
The recalled product
- 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…
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 402,968
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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