Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-0440-2014

November 05, 2013

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 66828
Status
Terminated
Classification
Class II
Quantity
274
Official record key
device-enforcement:Z-0440-2014

Official wording

Reason: 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.

Code information: UPN M0062502270, Catalog 250-227, Lot 15708431, 15708432, 15708433, 15812875, 15836355, 15855545, 15876213 , 15896950, 15935564, 16028474, 16044445, and 16046280

Distribution pattern: Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Ireland, Denmark, Italy, France, Canada, Great Britain, Switzerland, South Africa, Germany, and the Netherlands.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.