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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific ORISE Gel Syringe Submucosal Lifting Agent Kits

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  Class 2 Device Recall Boston Scientific ORISE Gel Syringe Submucosal Lifting Agent Kits see related information
Date Initiated by Firm October 10, 2022
Date Posted November 11, 2022
Recall Status1 Open3, Classified
Recall Number Z-0225-2023
Recall Event ID 90986
510(K)Number K171454  
Product Classification endoscopic injection needle, gastroenterology-urology - Product Code FBK
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
UPN:
(1)Twin Pack Box 1 M00519210;
(2)Twin Pack Box 10 M00519211;
(3)Single Pack Box 10 M00519231


Code Information GTIN Number : (1)08714729974581 (2)08714729974598 (3)08714729993865 All batches
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact Rebecca KinKead Rubio
508-683-4000
Manufacturer Reason
for Recall		 ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body reaction which presented as mass formations from remnant ORlSE Gel post-procedure, prompting surgical intervention
FDA Determined
Cause 2		 Under Investigation by firm
Action ***UPDATE 12/13/22** Boston Scientific issued Urgent Medical Device Product Removal Immediate Action Required Orise" Gel Submucosal Lifting Agent via Federal Express Priority Overnight mail on December 14, 2022, (as a Follow-Up To The Previous Product Advisory Dated October 10, 2022). Letter states reason for recall (Product Removal), health risk and action to take: Use and distribution of any remaining unused ORISE Gel Submucosal Lifting Agent products affected by this removal should cease immediately. For patients already treated with ORISE Gel, should the user identify submucosal distortions or mass formations in follow-up endoscopy, endoscopic ultrasound, imaging, or surgery, Boston Scientific recommends taking into account prior ORISE Gel use. Review pathology reports from the prior procedure to help determine the most appropriate course of action. Depending on the pathology present during the initial use of ORISE Gel, and whether it included conditions such as adenoma, high-grade dysplasia, or malignancy, a user may need to do nothing, repeat surveillance, repeat a biopsy, perform further mucosal resection, or plan surgical intervention to rule out any residual lesion. For each patient treated with ORISE Gel, Boston Scientific recommends appending their medical record with a copy of this letter to maintain awareness of this topic. If you identify any product from the affected lots within your inventory, please segregate the product immediately and return it to Boston Scientific in accordance with the enclosed Removal Instructions. If you are a distributor, please note that the depth of this removal is to the end user level and this notification should be forwarded to your customers. If you are a facility that has sent products to another hospital or facility within your network, please ensure that this notification is forwarded to them. Your local Sales Representative can answer any questions that you may have regarding this notification. _________________
Quantity in Commerce 402,968 Total
Distribution Worldwide Distribution: US (Nationwide) and (Foreign) countries of: Algeria Argentina Argentina Australia Austria Bahrain Belgium Brazil Canada Chile Colombia Costa Rica Cyprus Czech Republic Denmark Ecuador Egypt Finland France Germany Great Britain Greece Hong Kong Hungary Iceland Iraq Ireland Israel Italy Jordan Kuwait Latvia Lebanon Lithuania Luxembourg Mexico Netherlands New Zealand Norway Oman Palestine Panama Per¿ Poland Portugal Romania Russian Fed. Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Tunisia Unit.Arab Emir. Zimbabwe
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FBK and Original Applicant = Boston Scientific Corporation
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