Proxis™ Ureteral Access Sheath 231245Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741101724), received between Oct 2, 2018 and Mar 21, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Flaked” (3 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2026Flaked; Material Separation

  IT WAS REPORTED THAT AFTER REMOVING THE DILATOR, THE SHEATH WAS PEELING LIKE A SPLINTER ON THE INSIDE OF THE SHEATH TIP, END POINT. PER FOLLOW UP INFORMATION RECEIVED VIA RCC ON 19MAR2026, STATED THAT RATHER THAN COMPLETE DETACHMENT, IT APPEARS TO BE A FRAYING OR SPLITTING CONDITION, THOUGH THE EXACT NATURE WAS UNCLEAR AND ITS USE WAS DISCONTINUED IMMEDIATELY UPON NOTICING THE ISSUE, SO THERE WERE NO RESIDUAL FRAGMENTS LEFT IN THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24656979 ↗
• MalfunctionFeb 7, 2023Flaked; Flaked

  IT WAS REPORTED THAT THE INSIDE LINER OF PROXIS STARTED TO SHRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16317278 ↗
• MalfunctionFeb 9, 2021Device Contamination with Chemical or Other Material; Scratched Material; Device Contamination with Chemical or Other Material; Scratched Material

  IT WAS REPORTED THAT THE TRANSURETHRAL LITHOTRIPSY (TUL) IMPLEMENTATION CONFIRMED THAT THE LUMEN WAS SEEN LINT-LIKE UPON BLADDER STONE RETRIEVAL. PER ADDITIONAL INFORMATION RECEIVED VIA IBC ON 31JAN2021, THE FIBERS LIKE THREAD WERE ALLEGEDLY OBSERVED IN THE LUMEN.

  Patient problems: Foreign Body In Patient

  MAUDE report 11301620 ↗
• MalfunctionJan 26, 2021Flaked; Flaked

  IT WAS REPORTED THAT A URETHRAL CATHETER SHEATH WAS INSERTED TO ESTABLISH ACCESS, WHEN PERFORMING LITHOTRIPSY UNDER FLEXIBLE URETEROSCOPE. IT WAS STATED THAT AFTER THE FLEXIBLE URETEROSCOPE WAS INSERTED, MATERIALS ON THE INNER WALL OF THE SHEATH CAME OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11229323 ↗
• InjuryDec 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED THAT THE ACCESS SHEATH WAS NOT ABLE TO MOVE SMOOTHLY DURING THE PROCEDURE. THE USER REMOVED THE DEVICE TO FIND THE PATIENT HAD URETHRAL MUCOSAL DAMAGE. PER ADDITIONAL INFORMATION FROM THE IBC VIA EMAIL 25NOV2019, IT IS UNKNOWN IF THE PATIENT REQUIRED ANY FURTHER MEDICAL INTERVENTION, AND IT IS UNKNOWN THE CONDITION OF THE ACCESS SHEATH BEFORE THE PROCEDURE OCCURRED (WAS THE SHEATH SMOOTH, ROUGH, ETC.).

  Patient problems: Injury; Patient Problem/Medical Problem

  MAUDE report 9440115 ↗
• MalfunctionNov 11, 2019Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A LONG HAIR INSIDE OF THE SHEATH UPON OPENING THE PACKAGING.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9305412 ↗
• MalfunctionJan 10, 2019Device Damaged Prior to Use; Material Integrity Problem; Device Damaged Prior to Use

  IT WAS REPORTED THAT THERE WAS A BURR ON THE INNER CEASE. WHEN THE USER FOUND IT, THE SURGERY WAS COMPLETED AND NO ADDITIONAL DEVICE WAS USED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8233339 ↗
• MalfunctionNov 9, 2018Use of Device Problem; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE EXTRACTING STONE THROUGH THE SHEATH, THE LINING ON THE INNER SHEATH SCRAPED AND A THIN STRAND FELL OFF INTO THE RENAL PELVIS. THIS PIECE WAS REMOVED BY THE STONE BASKET WITH NO INJURY TO THE PATIENT.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8056929 ↗
• MalfunctionOct 2, 2018Break

  IT WAS REPORTED THAT THE URETERAL ACCESS SHEATH CAME APART WHILE INSIDE OF THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7926652 ↗