Boston Scientific Recalls Upsylon Y Mesh Kit Due to Sterility Concerns
Boston Scientific is recalling Upsylon Y Mesh Kits because pinholes may breach the sterile barrier, potentially rendering the device non-sterile and causing post-operative infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential sterile barrier breach leading to post-operative infection, which is a significant risk of harm, but the source text does not report any confirmed illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling the Upsylon Y Mesh Kit with Colpassist Vaginal Positioning Device. The recall is due to a potential for pinholes on the edge of the pouch, which could breach the sterile barrier. This breach may render the device non-sterile, posing a risk of post-operative infection.
The affected product is intended for use as a bridging material for sacrocolposuspension or sacrocolpopexy via laparotomy, laparoscopic, or robotic approach. The recall includes 8,524 units distributed worldwide, including the United States and numerous international countries. The recall covers all unexpired lots of the kit. While the Upsylon Y Mesh component itself is not impacted, the entire kit is being removed because the Colpassist Vaginal Positioning Device component is affected.
Healthcare providers and patients should stop using the affected kits. Boston Scientific is responsible for the recall and will manage the removal of the product from the market.
The recalled product
- Product
- UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic or robotic approach Material No.M0068318220 Individually packaged Upsylon Y Mesh (UPN…
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Surgical Mesh
- Affected units
- 8,524
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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