The Recall Desk

FDA (Devices) recall action 66828

Boston Scientific Corporation recalled 3 products on 2013-12-11

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2013-12-11
Critical
0
Units
1,662

Why these products were recalled

The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.

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.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2013-12-11

    Boston Scientific Recalls Navigator HD Ureteral Access Sheath Sets

    Boston Scientific is recalling Navigator HD Ureteral Access Sheath Sets because the dilator tip may separate from the body.

    Product
    Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog No 250-228, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2013-12-11

    Boston Scientific Recalls Navigator HD Ureteral Access Sheath Sets

    Boston Scientific is recalling 449 units of Navigator HD Ureteral Access Sheath Sets because the dilator tip may separate from the body.

    Product
    Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog M0062502290, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2013-12-11

    Boston Scientific Recalls Navigator HD Ureteral Access Sheath Sets

    Boston Scientific is recalling 274 units of Navigator HD Ureteral Access Sheath Sets because the dilator tip may separate from the body.

    Product
    Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Catalog No 250-227, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
    Category
    Distribution
    1 state