UroPass 61254BXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821925035423), received between Oct 11, 2022 and Nov 11, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2024Break; Break

  IT WAS REPORTED, THE URETERAL CATHETER TIP WAS FOUND TO BE BROKEN WHEN INSPECTED. THE ISSUE OCCURRED DURING RECEIPT INSPECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20657432 ↗
• InjuryApr 27, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING THERAPEUTIC CYSTOSCOPY, URETEROSCOPY AND LASER STONE, THE TIP OF THE UROPASS SHEATH BROKE INSIDE THE PATIENT. THE BITS WERE FISHED OUT OF THE BLADDER. THE PROCEDURE WAS DELAYED FOR FIVE MINUTES AND COMPLETED WITH A DIFFERENT SIZE ACCESS SHEATH. THE DEVICE WAS AN EXPIRED ITEM. THE DEVICE WAS INSPECTED BEFORE USE BUT DID NOT NOTICE IT WAS EXPIRED UNTIL THEY HAD TO "RISKMAN" THE INCIDENT. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16828705 ↗
• InjuryApr 11, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. THE DEVICE BROKE OFF IN THE PATIENT'S BLADDER. THERE WERE NO ANATOMICAL CHALLENGES OR PROCEDURAL DIFFICULTIES OBSERVED. THERE WAS NO ALLEGATION AGAINST THE OLYMPUS URETEROSCOPE THAT WAS USED CONCOMITANTLY. THE PATIENT HAD BEEN DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16718798 ↗
• InjuryOct 11, 2022Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED TO OLYMPUS, DURING A RETROGRADE INTRARENAL SURGERY (RIRS) TO REMOVE THE KIDNEY STONE, THE SUBJECT DEVICE BROKE DURING FIRST INSERTION INTO THE URETER. THE UROLOGIST REPORTED RESISTANCE WAS FELT, STOPPED ACTIONS, AND IDENTIFIED THE ACCESS SHEATH BROKE. THE DEVICE FRAGMENTS WERE REMOVED WITH AN UNKNOWN INSTRUMENT EASILY FROM THE BLADDER. THE SURGEON CONFIRMED THE PIECES WERE COMPLETED REMOVED WITH A CYSTOSCOPY. THE WAS A DELAY OF 'A FEW MINUTES' WHILE THE SURGEON WAS REMOVING THE DEVICE FRAGMENTS. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND A SIMILAR DEVICE WAS USED TO COMPLETED THE INTENDED PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15580652 ↗

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