UroPass 61154BXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925035386), received between Dec 8, 2022 and Dec 8, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K051593); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Sep 11, 2024Open, Classified

   Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients during surgical procedures.

   Z-0364-2025 · Root cause: Storage · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2022Material Separation; Material Separation

  THE CUSTOMER REPORTS DURING A CYSTO-URETEROSCOPY PROCEDURE USING A UROPASS URETERAL ACCESS SHEATH DILATOR, THE SHEATH TIP BROKE OFF INSIDE THE PATIENT¿S BLADDER WHEN THE PHYSICIAN WAS ATTEMPTING TO ADVANCE IT OVER THE WIRE INTO THE URETER. THE DEVICE FRAGMENTS WERE RETRIEVED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE." THERE WERE NO PROCEDURAL OR ANATOMICAL CHALLENGES THAT COULD HAVE CONTRIBUTED TO THE DEVICE BREAKING. THE CUSTOMER EXAMINED A LIKE DEVICE STILL SEALED IN THE PACKAGE. AFTER TRYING TO WIGGLE THE DEVICE INSIDE THE PACKAGE, THE DEVICE SNAPPED INSIDE THE PACKAGE. ADDITIONAL COMMENT BY PHYSICIAN "ADDITIONAL DEVICES WERE CHECKED WHILE IN THE PACKAGING/UNOPENED AND SHOWED SAME DEFECT." ONE IMAGE WAS PROVIDED SHOWING A DEVICE BROKEN IN THE PACKAGE. CLARIFYING INFORMATION HAS BEEN REQUESTED, AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE CUSTOMER STORES THE DEVICES IN STERILE CORE HANGING UP THE WAY THEY ARE DESIGNED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE PATIENT EVENT CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE DEVICE BROKEN IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15941597 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051593. One submission often covers many models, so check the product and lot details in each record.

• Z-2401-2023 · May 19, 2023 · Open, Classified
  UroPass Ureteral Access Sheaths, 5 pieces/box