Proxis™ Ureteral Access Sheath 231235Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741101717), received between May 2, 2017 and Sep 18, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Flaked” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Material Too Rigid or Stiff

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828913 ↗
• MalfunctionAug 22, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE, IT WAS DISCOVERED THAT THE TIP, END POINT OF THE PROXIS WAS CRACKED. THE USE OF THE PRODUCT WAS NOT APPROVED DUE TO THE POSSIBILITY OF DAMAGE TO THE MUCOUS MEMBRANES DURING INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20038817 ↗
• MalfunctionMay 8, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT PART OF THE URETERAL ACCESS SHEATH WAS SLIGHTLY BENT. THE DEVICE WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16886181 ↗
• MalfunctionMar 20, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ATTEMPTING TO INSERT THE ACCESS SHEATH, THE TIP BECAME SLIGHTLY BENT AND COULD NOT BE INSERTED PROPERLY. ALSO STATED IT WAS CRASHED. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON (B)(6) 2023, STATED THAT THE JAPANESE DESCRIPTION SAYS THAT THE TIP WAS BENT, AS IF IT HAD BEEN CRUSHED (PUSHED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16579262 ↗
• MalfunctionAug 5, 2019Flaked; Material Fragmentation; Flaked

  IT WAS REPORTED THAT THE PROXIS ACCESS SHEATH LEFT SHAVINGS IN THE PATIENTS' KIDNEY. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 8860700 ↗
• MalfunctionAug 5, 2019Nonstandard Device; Complete Blockage; Nonstandard Device

  IT WAS REPORTED THAT THE KIDNEY STONE GOT CAUGHT IN THE PROXIS ACCESS SHEATH DURING REMOVAL. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8860690 ↗
• InjuryApr 17, 2019Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT'S URETER ALLEGEDLY TORE WHEN THE PHYSICIAN INSERTED THE PROXIS ACCESS SHEATH INTO THE URETER. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6)2019 FROM THE INTERNATIONAL BUSINESS CENTER REPRESENTATIVE, THE PATIENT WAS ALREADY HOSPITALIZED AT THE TIME OF THE PROCEDURE AND WAS NOT HOSPITALIZED DUE TO THE COMPLICATION. THE PROCEDURE WAS DELAYED. THERE WAS MEDICAL INTERVENTION, AS A URETHRAL STENT WAS PLACED.

  Patient problems: Injury; Tissue Damage

  MAUDE report 8522220 ↗
• MalfunctionAug 16, 2018Flaked; Peeled/Delaminated; Component Missing; Flaked

  IT WAS REPORTED THE SHEATH PEELED DURING INSERTION AND REMOVAL OF THE FIBER SCOPE. THERE WERE NO MISSING PIECES. IT WAS LATER REPORTED ON (B)(6) 2018, THAT THE OUTSIDE OF THE TUBE OF THE SHEATH MAY HAVE PEELED.

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

  MAUDE report 7789541 ↗
• MalfunctionMay 19, 2017Material Deformation

  IT WAS REPORTED THAT DURING USE, THE INNER LINING ALLEGEDLY APPEARED TO BE SCRAPED OFF. THERAPY WAS COMPLETED ON THE SAME DEVICE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6578543 ↗
• MalfunctionMay 3, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE INNER LUMEN WAS SCRAPING OFF DURING THE PROCEDURE. THERE WAS, ALLEGEDLY, NO IMPACT TO THE PATIENT AND THE SAME DEVICE WAS USED THROUGHOUT THE TREATMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6540258 ↗
• MalfunctionMay 2, 2017Material Integrity Problem

  IT WAS REPORTED THAT THE INNER LINING LOOKED LIKE IT WAS SCRAPED OFF DURING USE. THERAPY WAS COMPLETED ON THE SAME DEVICE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6537213 ↗