Recall Z-1491-2021— Boston Scientific Corporation

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2021-04-15. FDA's recall record names no specific 510(k) clearance for this event. 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 M0068318200) is not impacted by this removal. Note: The UpsylonTM Y Mesh Kit consists of UpsylonTM Y Mesh and ColpassistTM Vaginal Positioning Device packaged and sterilized separately and then combined into a kit carton. This removal does not affect the UpsylonTM Y Mesh component of the kit, however, since the Colpassist device component is impacted, the entire UpsylonTM Y Mesh kit is being removed.. Reason: 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.

Recalling firm

Boston Scientific Corporation

Classification

Class II

Status

Ongoing

Initiated

2021-04-15

Firm location

Marlborough, MA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.