The Recall Desk

FDA (Devices) recall action 87709

Boston Scientific Corporation recalled 2 products on 2021-05-05

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2021-05-05
Critical
0
Units
13,073

Why these products were recalled

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

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2021-05-05

    Boston Scientific Recalls Colpassist Vaginal Positioning Device Due to Sterility Risk

    Boston Scientific is recalling Colpassist Vaginal Positioning Devices due to potential pinholes that may compromise sterility and cause post-operative infection.

    Product
    Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M0068318210
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-05-05

    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.

    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…
    Category
    Distribution
    0 states