AquaGuide® Ureteral Access Sheath 131135Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741052569), received between Jul 13, 2023 and Jul 19, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 19, 2023Inability to Irrigate; Inability to Irrigate

  IT WAS REPORTED THAT IN AN ONLINE SURVEY A PHYSICIAN STATED NO TO THE QUESTION WHEN THEY WERE ASKED IF THEY WERE ABLE TO SUCCESSFULLY INJECT FLUIDS. THE PHYSICIAN WAS NOT ABLE TO SUCCESSFULLY INJECT FLUIDS BECAUSE UNKNOWN IN RELATION TO 131135 ¿ AQUAGUIDE URETERAL ACCESS SHEATH ¿DILATOR 10FR/SHEATH DIAMETER 12/14FR, LENGTH 35CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17349309 ↗
• MalfunctionJul 13, 2023Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove

  IT WAS REPORTED THAT IN AN ONLINE SURVEY A PHYSICIAN STATED NO TO THE QUESTION WHEN THEY WERE ASKED IF THEY WERE ABLE TO SUCCESSFULLY INSERT AND REMOVE ENDOSCOPES AND RELATED INSTRUMENTS. THE PHYSICIAN WAS NOT ABLE TO SUCCESSFULLY INSERT AND REMOVE ENDOSCOPES AND RELATED INSTRUMENTS BECAUSE PHYSICIAN COULD NOT GET IT UP HIGH ENOUGH TO DO THAT IN RELATION TO 131135 - AQUAGUIDE® URETERAL ACCESS SHEATH ¿ DILATOR 10FR/SHEATH DIAMETER 12/14FR, LENGTH 35CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17316083 ↗