FDA (Devices) recall action 79608
The FDA (Devices) publishes a recall like this one as 11 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 11 pages.
Potential for Capio sutures to break and /or detach.
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.
Boston Scientific is recalling 21,051 units of Capio Open Access Box 4 sutures due to a potential for the sutures to break or detach during use.
Boston Scientific is recalling Uphold LITE w/ Capio SLIM devices due to a potential for the Capio sutures to break or detach.
Boston Scientific is recalling 4,144 units of Capio Standard Box 4 sutures because they may break or detach during surgery.
Boston Scientific Corporation is recalling 1,541 units of the Posterior LITE w/ Capio SLIM device because the sutures may break or detach.
Boston Scientific is recalling 1,258 Capio CL sutures because they may break or detach during transvaginal procedures.
Boston Scientific is voluntarily recalling 34 Pinnacle Anterior Apical pelvic floor repair kits due to a Class II safety concern. The devices were distributed worldwide.
Boston Scientific is recalling 60,538 units of Capio SLIM Box 5 sutures because they may break or detach during open surgery.
Boston Scientific is recalling 24 units of Pinnacle Posterior PFR Kits because the Capio sutures may break or detach.
Boston Scientific is recalling 1,002 Uphold Vaginal Support Systems because the Capio sutures may break or detach.
Boston Scientific is recalling 21,250 units of the Capio SLIM Suture Capturing Device because the sutures may break or detach during surgery.
Boston Scientific is recalling 2,567 units of Capio RP sutures because they may break or detach during surgery.