Proxis™ Ureteral Access Sheath 231025Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741101670), received between Jul 9, 2019 and Jul 2, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Misassembled” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE URETERAL ACCESS SHEATH HANDLE PART WAS BROKEN AND CANNOT BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383944 ↗
• MalfunctionMay 25, 2022Disconnection; Material Fragmentation; Disconnection; Material Fragmentation

  IT WAS REPORTED THAT THE ACCESS SHEATH BROKE IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14497759 ↗
• MalfunctionAug 4, 2020Difficult to Remove

  IT WAS REPORTED THAT UPON COMPLETION OF THE CASE, THE OPERATOR WAS NOT ABLE TO REMOVE THE ACCESS SHEATH FROM THE SCOPE.

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

  MAUDE report 10364537 ↗
• 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 8773334 ↗
• 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 8773331 ↗
• MalfunctionJul 9, 2019Misassembled; Misassembled; Inadequacy of Device Shape and/or Size

  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 8773062 ↗