UroPass 61346BXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925035454), received between Nov 10, 2021 and Nov 10, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionNov 10, 2021Break; Break

  AS REPORTED, DURING TRANSURETHRAL LITHOTOMY PROCEDURE, THE ROOT OF THE SHEATH BROKE ABOUT 20 MINUTES AFTER THE START OF USE. THE COIL OF THE SHEATH DID NOT CAME OUT. THE DEVICE WAS REPLACED WITH SIMILAR DEVICE AND THE INTENDED PROCEDURE WAS COMPLETED WITH NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12789924 ↗

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