The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0440-2014·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural defect in a medical device used in invasive procedures where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Boston Scientific Corporation is recalling 274 units of the Navigator HD 13F/15F x 28 cm Ureteral Access Sheath Set. The product is sterile and indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments, and for the injection of fluids into the urinary tract.

The recall was initiated after the company received five reports that the tip of the dilator separated from the body of the dilator. The affected units are identified by Product No M0062502270, RDF Catalog No 250-227, and specific lot numbers including 15708431, 15708432, 15708433, 15812875, 15836355, 15855545, 15876213, 15896950, 15935564, 16028474, 16044445, and 16046280.

The affected products were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in Australia, Ireland, Denmark, Italy, France, Canada, Great Britain, Switzerland, South Africa, Germany, and the Netherlands. Healthcare providers and facilities should stop using the affected devices and contact Boston Scientific for further instructions.

The recalled product

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.
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Urological Instrument
Hazard
Affected units
274

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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