Boston Scientific recalls Upsylon Y Mesh Kit with Colpassist Vaginal Positioning Device due to potential pinholes causing sterile barrier breaches and post-operative infections. Affected lots listed; contact for return instructions.
Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection
Boston Scientific is recalling its Upsylon Y Mesh Kit with Colpassist Vaginal Positioning Device because pinholes on the pouch edge could compromise sterility, leading to infections after surgery. This affects specific product lots sold between certain dates.
The pouch edge of the device may develop pinholes during manufacturing, which could breach the sterile barrier. If the device isn't properly sterile, it might cause infections after surgery.
Women who received this specific surgical kit for pelvic floor procedures are most at risk. Patients who have the affected lot numbers listed in the recall should check their product.
Check for the product name 'Upsylon Y Mesh Kit with Colpassist Vaginal Positioning Device' and lot numbers listed in the recall (e.g., C003726, C003737). The kit is intended for pelvic floor surgery procedures.
Look for the lot numbers listed in the recall (e.g., C003726, C003737) on the packaging.
Reach out to Boston Scientific for instructions on returning the kit if you have the affected lot numbers.
No, the Upsylon Y Mesh component itself is not impacted by this recall. Only the Colpassist Vaginal Positioning Device part of the kit is affected.
The risk is that pinholes on the pouch edge could breach the sterile barrier, potentially causing post-operative infections if the device is not properly sterile.
Check the lot numbers on the packaging; affected lots include C003726, C003737, and other numbers listed in the recall notice.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1491-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1491-2021 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.
