FDA Device Intelligence
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Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse

FDA product code PWI · Class 2 · Obstetrics/Gynecology

2
Registered devices
239
Adverse events
13
Recalls
2
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2024-06-27Boston Scientific CorporationSome lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.
2024-06-27Boston Scientific CorporationSome lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.
2018-02-12Boston Scientific CorporationPotential for Capio sutures to break and /or detach.
2018-02-12Boston Scientific CorporationPotential for Capio sutures to break and /or detach.
2018-02-12Boston Scientific CorporationPotential for Capio sutures to break and /or detach.
2018-02-12Boston Scientific CorporationPotential for Capio sutures to break and /or detach.
2018-02-12Boston Scientific CorporationPotential for Capio sutures to break and /or detach.
2018-02-12Boston Scientific Corporation
2018-02-12Boston Scientific CorporationPotential for Capio sutures to break and /or detach.
2018-02-12Boston Scientific CorporationPotential for Capio sutures to break and /or detach.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.