Boston Scientific recalls ORISE Gel Syringe Submucosal Lifting Agent Kits due to higher incidence of foreign body reactions causing mass formations that may require surgical intervention after gastrointestinal 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 Syringe Submucosal Lifting Agent Kits used in gastrointestinal procedures because remnants of the gel can cause foreign body reactions, leading to mass formations that may require surgery. This risk applies to kits sold with specific model numbers and batch ranges.
Remnants of the ORISE Gel after procedures can cause foreign body reactions in the body, forming mass-like structures that may require surgical removal. This reaction occurs after the gel is used during endoscopic procedures for polyp or lesion removal.
Patients undergoing gastrointestinal endoscopic procedures who used these kits are at risk. Medical professionals using the kits for polyp or lesion removal may also be affected.
Check for kits with model numbers M00519210, M00519211, or M00519231. These kits were sold with specific GTIN numbers and batch ranges across all production batches.
Identify the model number on the kit packaging to determine if it matches M00519210, M00519211, or M00519231.
Reach out to Boston Scientific for guidance on next steps if you have the recalled kits.
Boston Scientific recalls these kits due to higher incidence of foreign body reactions after procedures, which can cause mass formations requiring surgical intervention.
Remnants of the gel can cause foreign body reactions, forming mass-like structures that may require surgery after gastrointestinal procedures.
Check for model numbers M00519210, M00519211, or M00519231 on the packaging, which were sold with specific GTIN numbers and batch ranges.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0225-2023 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0225-2023 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.
