Proxis™ Ureteral Access Sheath 231225Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741101700), received between Mar 12, 2018 and Nov 24, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Misassembled” (4 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.

• MalfunctionNov 24, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH ITEM # 231225 DURING SURGERY. THE ACCESS SHEATH BROKE IN HALF, AND THE SURGEON HAD TO RETRIEVE THE OF SHEATH. PER CUSTOMER FOLLOW UP RESPONSE RECEIVED VIA EMAIL ON 21JAN2026, IT WAS REPORTED THAT THE PRODUCT WAS NO LONGER AVAILABLE TO BE RETURNED. THERE WAS NO PATIENT IMPACT, AND THE BROKEN ITEM WAS REMOVED IN ENTIRETY BY THE DOCTOR.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632789 ↗
• MalfunctionSep 21, 2020Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PACKAGE WAS FOUND TO BE BROKEN SO IT WAS NOT KEPT STERILE AND WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10563423 ↗
• MalfunctionJul 10, 2019Misassembled; Misassembled; Structural Problem; Defective Device; Difficult to Advance

  IT WAS REPORTED THAT THE HOLE OF THE FUNNEL PART OF THE PROXIS ACCESS SHEATH WAS TOO SMALL IN DIAMETER, CAUSING THE INNER SHEATH TO GET CAUGHT WHEN IT WAS BEING INSERTED ABOUT AN INCH FROM THE TIP. NO PATIENT IMPACT REPORTED.

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

  MAUDE report 8775990 ↗
• MalfunctionJul 10, 2019Misassembled; Difficult to Insert; Misassembled

  IT WAS REPORTED THAT THE HOLE OF THE FUNNEL PART OF THE PROXIS ACCESS SHEATH WAS TOO SMALL IN DIAMETER, CAUSING THE INNER SHEATH TO GET CAUGHT WHEN IT WAS BEING INSERTED ABOUT AN INCH FROM THE TIP. NO PATIENT IMPACT REPORTED.

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

  MAUDE report 8775986 ↗
• MalfunctionJul 10, 2019Misassembled; Difficult to Insert; Misassembled

  IT WAS REPORTED THAT THE HOLE OF THE FUNNEL PART OF THE PROXIS ACCESS SHEATH WAS TOO SMALL IN DIAMETER, CAUSING THE INNER SHEATH TO GET CAUGHT WHEN IT WAS BEING INSERTED ABOUT AN INCH FROM THE TIP. NO PATIENT IMPACT REPORTED.

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

  MAUDE report 8775847 ↗
• MalfunctionJul 9, 2019Misassembled; Difficult to Insert; Misassembled

  IT WAS REPORTED THAT THE HOLE OF THE FUNNEL PART OF THE PROXIS ACCESS SHEATH WAS TOO SMALL IN DIAMETER, CAUSING THE INNER SHEATH TO GET CAUGHT WHEN IT WAS BEING INSERTED ABOUT AN INCH FROM THE TIP. NO PATIENT IMPACT REPORTED.

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

  MAUDE report 8773592 ↗
• MalfunctionSep 12, 2018Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS PLASTIC COMING OUT OF THE INSIDE OF THE SHEATH. THE PLASTIC FOUND INSIDE OF THE SHEATH WAS NOT PART OF THE DEVICE. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7868012 ↗
• InjuryJul 12, 2018Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT ALLEGEDLY EXPERIENCED A PERFORATED URETER DURING A STONE REMOVAL PROCEDURE. THE PATIENT WAS SEEN A WEEK BEFORE THE PROCEDURE AND HAD A STENT PLACED TO HELP WITH RELAXATION AND DILATION OF THE URETER. THE DOCTOR PERFORMED THE PROCEDURE AND STATED THAT THE SHEATH WENT IN SMOOTHLY. AFTER REMOVING THE STONE THE DOCTOR TOOK THE SCOPE UP THE URETER AND FOUND THERE WAS A TEAR IN THE PROXIMAL URETER. THE DOCTOR IMMEDIATELY PLACED A STENT. THE PATIENT HAD A FOLLOW UP WITH IN A WEEK.

  Patient problems: Internal Organ Perforation; Uterine Perforation

  MAUDE report 7681568 ↗
• MalfunctionMar 12, 2018Detachment Of Device Component; Material Separation

  IT WAS REPORTED THAT A PIECE OF THE INNER LUMEN OF THE ACCESS SHEATH SHREDDED OFF DURING THE PROCEDURE. THE PIECE WAS ABLE TO BE REMOVED FROM THE PATIENT DURING THE SAME PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7330779 ↗