UroPass 61024BXRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00821925035317), received between Apr 21, 2022 and Mar 7, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2024Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT DURING A PROCEDURE TO ACCESS THE URETER, THE SURGEON HAD DIFFICULTY INSERTING THE SHEATH. WHEN THE SHEATH WAS TAKEN OUT OF THE PATIENT, THERE WAS A CRACK NOTED NEAR THE TIP AND THE TIP SUBSEQUENTLY BROKE WHEN PLACED ON THE OPERATING TABLE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS AN UNSPECIFIED DELAY; HOWEVER, THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18861983 ↗
• InjuryJun 9, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING THERAPEUTIC URETEROSCOPY, THIS URETERAL CATHETER TIP BROKE OFF IN PATIENT. THE SURGEON WAS ABLE TO RETRIEVE ALL PARTS FROM THE PATIENT. THE PROCEDURE WAS PROLONGED WITH AN UNKNOWN AMOUNT OF TIME. THE INTENDED PROCEDURE WAS COMPLETED WITH INTERVENTION PROCEDURE. THE DEVICE WAS INSPECTED PRIOR TO USE. THE CUSTOMER CONFIRMED THEY KNEW THE STOCK WAS EXPIRED BUT DECIDED TO USE IT ANYWAY. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17100946 ↗
• MalfunctionMay 8, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TIP OF THE OUTER SHEATH OF THE DEVICE WAS TORN AT THE START OF THE PROCEDURE (AN UNSPECIFIED PROCEDURE). THE DEVICE WAS NOT USED ON PATIENT. THE DEVICE WAS REPLACED AND THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16892249 ↗
• InjuryNov 3, 2022Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTS DURING A PRIMARY PYELOSCOPY AND LASER TO RIGHT KIDNEY STONE USING A SINGLE USE ACCESS AND AN URETERO-RENO-VIDEOSCOPE, WHEN ATTEMPTING TO REMOVE THE SCOPE AFTER THE LASER OF THE RENAL STONE HAD BEEN COMPLETED, THE PHYSICIAN WAS UNABLE TO WITHDRAWAL THE SCOPE THROUGH THE ACCESS SHEATH. RESISTANCE WAS NOTED BEFORE THE TOP OF THE SCOPE WAS ABLE TO ENTER ACCESS SHEATH. THE SCOPE BECAME STUCK AND RESULTED IN A URETERIC AVULSION. THE PROCEDURE WAS ABORTED, AND AN URGENT PERCUTANEOUS NEPHROSTOMY WAS PERFORMED. THE PATIENT WAS HOSPITALIZED FOR 5 DAYS AND WAS GIVEN IV ANTIBIOTICS, A PERCUTANEOUS NEPHROSTOMY TUBE AND IMAGING. THE PATIENT IS CURRENTLY SCHEDULED TO HAVE A NEPHRECTOMY. AFTER WITHDRAWAL, IT WAS NOTED THERE WAS DAMAGE TO THE ACCESS SHEATH WHICH IS BELIEVED BY THE SURGICAL TEAM TO BE THE REASON THE SCOPE WAS UNABLE TO BE WITHDRAWN NORMALLY FROM THE URETER. THE SCRUB NURSE CONFIRMED SCOPE LOOKED NORMAL AND IN GOOD CONDITION PRIOR TO INSERTION INTO THE PATIENT URETER. IMAGES OF THE SCOPE AND DEVICE USED IN THIS PROCEDURE WERE RECEIVED. THE PHOTO OF THE WHITE TIP SHOWS THAT THE DILATOR TIP HAS BEEN BROKEN OFF. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE ACCESS

  Patient problems: Unspecified Kidney or Urinary Problem

  MAUDE report 15722159 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED A LITERATURE TITLED "PROGNOSTIC FACTORS FOR THE SAFETY AND EFFICACY OF RETROGRADE LASER LITHOTRIPSY: DATA FROM A CONTEMPORARY SERIES OF 155 CONSECUTIVE PATIENTS WITH SINGLE AND MULTIPLE LITHIASIS OF THE URINARY TRACT". THIS PROSPECTIVE STUDY WAS AIMED TO EVALUATE THE RESULTS AND COMPLICATIONS OF RETROGRADE ENDOSCOPIC LITHOTRIPSY FOR STONES LOCATED IN THE URINARY TRACT AND TO DETERMINE PROGNOSTIC FACTORS FOR TREATMENT OUTCOME. THE PROGNOSTIC FACTORS FOR THE STONE-FREE RATE (SFR) AFTER THE 1ST AND SUBSEQUENT SESSIONS AND OVERALL COMPLICATIONS WERE ASSESSED. PATIENTS WERE DIVIDED INTO SINGLE OR MULTIPLE LITHIASIS GROUPS (GROUPS A AND B RESPECTIVELY). A COMPARISON BETWEEN THESE TWO GROUPS WAS THEN CONDUCTED. OVERALL, 237 STONES WERE DETECTED IN 155 PATIENTS, REPRESENTING A MEAN BURDEN OF 1.53 STONES PER PATIENT. THE MEAN TOTAL STONE SIZE WAS 14.7 MM, THE INITIAL SFR WAS 80% AND THE FINAL SFR (AFTER A MEAN OF 1.23 SESSIONS PER PATIENT) WAS 94.2%. THE RATE OF COMPLICATIONS WAS 26.4%. MULTIVARIATE ANALYSIS REVEALED THAT PREOPERATIVE STENTING AND TOTAL STONE SIZE WERE INDEPENDENT PROGNOSTIC FACTORS OF INITIAL SFR, WHILE NO INDEPENDENT FACTORS WERE DETERMINED FOR FINAL SFR.

  Patient problems: Hematuria; Myocardial Infarction; Unspecified Kidney or Urinary Problem; Urinary Tract Infection

  MAUDE report 14166831 ↗

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