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Recall Observatory FDA recall evidence

Device 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.

Z-0442-2014

November 05, 2013

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 66828
Status
Terminated
Classification
Class II
Quantity
449
Official record key
device-enforcement:Z-0442-2014

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 M0062502290, Catalog 250-229, 15579545, 15579546, 15615465, 15630771, 15630772, 15688533, 15688534, 15813601, 15823202, 15880464, 15927981, 16159896, 16175942, 16196763, 16373048,

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.