UroPass 61046BXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821925035331), received between Jan 25, 2021 and Aug 3, 2021 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2021Break; Break

  UPDATES ON THE EVENT REPORTED: FURTHER COMMUNICATION WITH THE CUSTOMER CONVEYED THE FOLLOWING INFORMATION: CUSTOMER STATED THAT THE SUBJECT DEVICE IS NOT RETURNING FOR EVALUATION. THE SUBJECT DEVICE WAS DISPOSED. THE INTENDED PROCEDURE WAS COMPLETED (DID NOT PROVIDE THE TYPE/SPECIFIC PROCEDURE). CUSTOMER STATED NO PATIENT HARM, NO USER INJURY. NO FURTHER DETAILS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268615 ↗
• MalfunctionJun 30, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT USER FOUND A FOREIGN OBJECT INSIDE THE STERILE PACKAGE BEFORE ITS USE. NO PATIENT HARM OR INJURY OCCURRED DUE TO THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12094870 ↗
• MalfunctionMay 5, 2021Break; Break

  A REPORT OF DILATOR TIP WAS BROKEN AND THE BROKEN PIECES FELL INTO THE PATIENT DURING A RETROGRADE INTRARENAL SURGERY PROCEDURE. THE USER INSERTED THE DEVICE AND FELT SOME RESISTANCE FROM THE PRODUCT WHICH WAS DIFFERENT FROM THE NORMAL USE. THE END DILATOR WAS CHECKED AND FOUND BROKEN PIECES FELL INTO THE PATIENT. EACH BROKEN PIECE WAS FOUND AND REMOVED FROM THE PATIENT BLADDER AND LOWER URETER. THE BROKEN PIECES WERE RETRIEVED USING FORCEPS WITH RIGID CYSTOSCOPE AND RIGID URETEROSCOPE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11776471 ↗
• InjuryJan 25, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  AS REPORTED, DURING THE REMOVAL OF A STONE BY THE UROPASS DEVICE, THE MATERIAL WAS REMOVED FROM THE UROPASS AND FELL INTO THE PATIENT. ALL THE PIECES OF THE STONE WERE SUCCESSFULLY REMOVED FROM THE PATIENT. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11224348 ↗

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