Medical Device Procedure Kits Recalled for Foreign Body Reaction Risk
Boston Scientific recalls ORISE ProKnife Procedure Kits due to higher incidence of foreign body reactions to remnant gel post-procedure, which have required surgical intervention in affected patients.
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 FDA Class II recall involves foreign body reactions requiring surgical intervention, meeting the rubric criterion for Severe severity. Surgical intervention represents a serious adverse outcome requiring hospitalization.
Plain-English summary
Boston Scientific Corporation is recalling ORISE ProKnife Procedure Kits used in gastrointestinal endoscopic procedures. These kits are indicated for submucosal lift of polyps, adenomas, early-stage cancers, and other gastrointestinal mucosal lesions prior to removal. Three models are affected: the 1.5mm, 2.0mm, and 3.0mm electrode kits.
The company identified a higher incidence of foreign body reactions to remnant ORISE Gel remaining after the procedure. These foreign body reactions manifested as mass formations requiring surgical intervention.
Approximately 402,968 kits have been distributed worldwide, including throughout the United States and numerous foreign countries. All batches of the affected models are included in this recall.
The recalled product
- Product
- ORISE ProKnife Procedure 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.…
- 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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