Boston Scientific recalls ORISE Gel Submucosal Lifting Agent due to higher incidence of foreign body reactions causing mass formations that may require surgical intervention after procedures.
***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 Gel Submucosal Lifting Agent used in gastrointestinal procedures because it can cause foreign body reactions leading to mass formations that may require surgery. This risk occurs after the gel is removed from the body during procedures.
The gel can cause foreign body reactions where remnants of the gel form mass structures inside the body after removal. These masses may require surgical intervention to remove, posing a risk of complications from the procedure.
Patients who received ORISE Gel during endoscopic procedures for gastrointestinal polyps or lesions are affected. Those with a history of foreign body reactions may be at higher risk.
Check for the product name 'ORISE Gel Submucosal Lifting Agent' used in gastrointestinal endoscopic procedures. The product comes in Twin Packs (M00519200, M00519201) or Single Packs (M00519220, M00519221) with specific GTIN numbers.
Reach out to Boston Scientific directly to confirm if you have the recalled product and get instructions for next steps.
Boston Scientific recalls ORISE Gel due to higher incidence of foreign body reactions causing mass formations that may require surgical intervention after procedures.
Remnants of the gel can form mass structures inside the body, potentially requiring surgery to remove.
Check for the product name 'ORISE Gel Submucosal Lifting Agent' used in gastrointestinal endoscopic procedures. The product comes in Twin Packs (M00519200, M00519201) or Single Packs (M00519220, M00519221) with specific GTIN numbers.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0224-2023 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0224-2023 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.
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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.
