UroPass 61146BXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821925035379), received between Jan 7, 2021 and Oct 15, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Fell” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE TIP OF THE UROPASS ACCESS SHEATH WAS DAMAGED WHEN IT WAS TAKEN OUT OF THE BOX. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20457753 ↗
• MalfunctionSep 21, 2021Structural Problem; Sharp Edges; Structural Problem; Sharp Edges

  AS REPORTED, THE USER FOUND THE SHAPE OF THE DILATOR TIP END ABNORMAL, IT HAS STRAIGHT SECTION HOWEVER, THE SUBJECT DEVICE HAS A LITTLE DIAGONAL CROSS SECTION. AS THE USER FELT RESISTANCE WHEN INSERTING THE UROPASS ON THE PROCEDURE, IT TOOK IT OUT FROM THE PATIENT BODY AND CHECKED THIS ABNORMALITY. THE ISSUE FOUND DURING A THERAPEUTIC RIRS (RETROGRADE INTRARENAL SURGERY) PROCEDURE. THE SUBJECT DEVICE WAS NOT USED ON THE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT WITH NO INJURY OR HARM TO THE PATIENT. THERE WAS NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12509457 ↗
• MalfunctionSep 16, 2021Material Frayed; Device Fell; Material Frayed; Device Fell

  AS REPORTED, THE USER WERE USING THE DEVICE DURING A STONE MANIPULATION PROCEDURE. WHEN THE DEVICE WAS PUT OVER THE GUIDE WIRE AND THEN PUT INTO THE PATIENT THE USER NOTICED AN ISSUE. THE USER NOTICED THAT THE VERY TIP OF THE PRODUCT, THE WHITE PIECE, HAD FRAYED AND FELL OFF INTO THE PATIENT. THE PIECE THAT FELL OFF WAS RETRIEVED FROM THE PATIENT WITH A FLEXIBLE GRASPER WITH NO REPORTED ADVERSE EVENT TO THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE IS NO PATIENT HARM OR INJURY ASSOCIATED ON THIS REPORTED EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12484542 ↗
• InjuryJan 7, 2021Material Separation; Material Separation

  IT IS REPORTED DURING A CYSTOSCOPY USING A UROPASS ACCESS SHEATH, THE DISTAL FIVE INCHES OF THE INNER CANNULA SEPARATED AND WAS RETAINED INSIDE THE PATIENT. EVENT DETAILS AS FOLLOWS: THE DOCTOR STATED THAT THE PROCEDURE STARTED NORMALLY, WITH INTRODUCING THE CYSTOSCOPE TO SURVEY THE BLADDER. HE THEN PLACED A GLIDEWIRE UP THE URETER, THEN PLACED A SECOND WIRE UP. NEXT, THE ACCESS SHEATH WAS INTRODUCED. WHEN THE DOCTOR REMOVED THE INNER CANNULA OF THE ACCESS SHEATH, IT WAS APPARENT THE DISTAL 5 INCHES OF THE INNER CANNULA HAD DETACHED. THE PROCEDURE WAS NOT COMPLETED. A 5-INCH SEGMENT OF THE DISTAL END OF THE INNER CANNULA WAS RETAINED INSIDE THE PATIENT. THE PATIENT REPORTED PAIN DUE TO THE RETAINED DEVICE FRAGMENT. ON AN UNSPECIFIED DATE, THE PATIENT UNDER WENT A SECOND PROCEDURE DURING WHICH THE DEVICE FRAGMENT WAS REMOVED WITH NO FURTHER CONSEQUENCES REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11131694 ↗

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