Bardex® Lubricath® Foley Catheter 0165L26Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741017537), received between May 2, 2017 and Nov 11, 2019 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2019Difficult to Remove; Fluid/Blood Leak; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT SAID WHEN THE WATER IS DRAINED OUT, THE BALLOON IS LARGER THAN WHERE HER INSICION WAS MADE.

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

  MAUDE report 9305631 ↗
• MalfunctionOct 23, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS AN UNKNOWN LEAK FROM 2 OF THE CATHETERS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9226762 ↗
• MalfunctionOct 11, 2019Fluid/Blood Leak; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS AN UNKNOWN LEAK FROM TWO OF THE CATHETERS. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 9179256 ↗
• MalfunctionOct 8, 2019Deflation Problem; Leak/Splash; Device Fell; Deflation Problem

  IT WAS REPORTED THAT THE CATHETER FELL OUT OF THE PATIENT AND WAS NOTED THAT IT HAD ¿MICRO LEAKS¿ FROM THE BALLOON. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 9165860 ↗
• MalfunctionMar 5, 2018Failure to Infuse; Inflation Problem; Failure to Infuse

  IT WAS REPORTED THAT THE CATHETER BALLOON WOULD NOT INFLATE. THE COMPLAINANT REPORTED THAT THE BALLOON APPEARED INTACT AND THAT THERE WERE NO MISSING PIECES OBSERVED.

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

  MAUDE report 7314174 ↗
• MalfunctionMar 5, 2018Failure to Infuse; Inflation Problem; Failure to Infuse

  IT WAS REPORTED THAT THE CATHETER BALLOON WOULD NOT INFLATE. THE COMPLAINANT REPORTED THAT THE BALLOON APPEARED INTACT AND THAT THERE WERE NO MISSING PIECES OBSERVED.

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

  MAUDE report 7314030 ↗
• InjuryMay 2, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE URINE WOULD NOT DRAIN THROUGH THE CATHETER. PATIENT ALSO TRIED TO IRRIGATE THE CATHETER BUT NO LIQUID WAS RETURNED. THE PATIENT HAD TO DEFLATE THE BALLOON TO ALLOW THE URINE TO DRAIN THROUGH. HE WAS ABLE TO REMOVE THE CATHETER WITHOUT ANY ISSUES. THE PATIENT ALLEGEDLY DEVELOPED A BLADDER INFECTION SHORTLY AFTER, AND HAD TO VISIT A DOCTOR. HE WAS NOT PRESCRIBED ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 6536589 ↗