Boston Scientific recalls ORISE ProKnife Procedure Kits due to higher risk of foreign body reactions from remnant gel post-procedure, requiring surgical intervention in some cases.
***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
Boston Scientific is recalling ORISE ProKnife Procedure Kits used in gastrointestinal procedures because remnants of the gel can cause foreign body reactions that may require surgery. This recall affects kits sold with specific model numbers and GTINs.
Remnant ORISE Gel left in the body after procedures can cause foreign body reactions, forming mass-like structures that may require surgical removal. This reaction occurs in some patients after the procedure and can lead to complications.
Healthcare professionals using ORISE ProKnife Procedure Kits for gastrointestinal procedures are most at risk. Patients who have undergone procedures with these kits may also be affected.
Check for model numbers M00519380, M00519390, or M00519400 on the kit packaging. These kits were sold with GTIN numbers 08714729995586, 08714729995593, or 08714729995609.
Identify the model number on the kit packaging to determine if it is affected.
Reach out to Boston Scientific for guidance on next steps if you have the recalled kit.
Remnant ORISE Gel can cause foreign body reactions that form mass-like structures, requiring surgical intervention in some cases.
Check for model numbers M00519380, M00519390, or M00519400 on the kit packaging.
The recall does not require immediate discontinuation; healthcare professionals should contact Boston Scientific for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0226-2023 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0226-2023 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
