Recall Z-0226-2023 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
Boston Scientific Corporation
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. UPN (1)ORISE ProKnife 1.5 mm Electrod
| Date | Nov 11, 2022 (initiated Oct 10, 2022) |
| Status | Open, Classified |
| Reason | ***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 |
| Root cause | 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 distor |
| Quantity | 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 Isr |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171454 | Interject Injection Therapy Needle Catheter Boston Scientific Corporation, Jul 7, 2017 |