UroPass 61338BXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821925035447), received between Dec 22, 2021 and Dec 28, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Separation” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 28, 2022Material Separation; Material Separation

  C22475559 MODEL# 61154BX / LOT # 09J1800111

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16061958 ↗
• InjuryDec 22, 2021Material Separation; Material Separation

  THE CUSTOMER REPORTS DURING AN X-RAY FOLLOWING A TRANSURETHRAL URINARY CALCULUS REMOVAL PROCEDURE USING A UROPASS SHEATH, A FOREIGN BODY WAS FOUND TO REMAIN IN THE URINARY TRACT. A SECOND FLEXIBLE TRANSURETHRAL URETEROLITHOTRIPSY (F-TUL) WAS PERFORMED AND THE FOREIGN BODY WAS COLLECTED. THE FOREIGN BODY WAS ABOUT 10 MM IN LENGTH, WHITE, AND HAD CRACKS AROUND 4 MM FROM THE TIP. THE STUMP HAD BEEN TORN DIAGONALLY. THE CUSTOMER SPECULATES IT IS THE TIP OF THE UROPASS SHEATH THAT MAY HAVE BEEN BROKEN WHEN THE STONES WERE COLLECTED USING THE BASKET FORCEPS. THERE WERE NO ADDITIONAL CONSEQUENCES TO THE PATIENT REPORTED. ADDITIONAL DETAILS REGARDING THE PATIENT AND EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13065954 ↗

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