Boston Scientific recalls Colpassist vaginal positioning devices due to potential pinholes causing sterile barrier breaches and post-operative infections. Affected units include specific lot numbers from 2023-2024.
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 vaginal positioning devices used in gynecological surgery because pinholes on the device edge might compromise sterility, leading to infections after surgery. This recall affects specific lot numbers produced between 2023 and 2024.
The device's pouch edge can develop pinholes during manufacturing, which may breach the sterile barrier. If the device is not sterile, it could lead to infections after surgery.
Healthcare providers using the Colpassist device for gynecological procedures are most at risk. Patients who have undergone surgery with this device may need to check if they were using an affected lot.
Check the lot numbers listed: C003699, C003715, C003735, C003750, C003775, C003804, C003813, C003842, C003853, C003887, C003905, C003936, C003950, C003960, C003966, C003986, C003997, C004028, C004041, C004078, C004091, C004107, C004117, C004128, C004136, C004160, C004186, C004206, C004221. The device is intended for use in gynecological surgery to position the vagina during procedures.
Look for the lot number on the device packaging or label. Affected lots are listed in the recall notice.
Reach out to Boston Scientific directly for further guidance on handling the device if it is affected.
The device may have pinholes that could breach sterility, so it is not safe for use in surgery without checking the lot number.
Check the lot number against the list provided in the recall notice. If it matches, contact Boston Scientific for instructions.
The recall is about potential sterility issues; proper surgical protocols and sterile handling should be followed as per standard medical practices.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1490-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1490-2021 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.
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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.
