Bardex® I.C. Foley Catheter 0166SI20Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741016868), received between Apr 30, 2018 and Sep 5, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Urinary Tract Infection

  MAUDE report 50634882 ↗
• InjuryOct 4, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT FOLEY CATHETER LUBRICANT WAS HARD TO INSERT AND REMOVE FROM THE PATIENT. THE CUSTOMER THOUGHT PRODUCT MIGHT BE OLD. ALSO STATED THAT COUPLE OF URINARY TRACT INFECTION CAUSED BECAUSE OF RESISTANCE OF PUTTING ON AND REMOVING THE CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 12568275 ↗
• MalfunctionMay 5, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS INSERTED TO THE PATIENT AND AFTER FOUR HOURS IT WAS NOTED THAT THERE WAS NO URINE PASSED THROUGH THE CATHETER. THE NURSE THEN USED THE BACK UP THAT CUSTOMER HAD AND IT WORKED FINE. DUE TO USE OF BACK UP FOLEY ITEMS THEY WANT THE TRAY AND THE FOLEY TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11777069 ↗
• MalfunctionApr 20, 2021Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE PATIENT FELT THE TIP OF THE CATHETER JABBING. IT WAS ALSO REPORTED THAT THE NURSE THOUGHT THE SILVER LATEX WAS CAUSING THE PATIENT SPASMS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 11695537 ↗
• MalfunctionNov 19, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOONS ON 20 FRENCH 30 ML SILVER TIPPED NON-LATEX CATHETERS WERE DEFLATED DUE TO HOLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10871548 ↗
• MalfunctionOct 15, 2019Inaccurate Flow Rate; Obstruction of Flow; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS REMOVED FROM THE PATIENT BECAUSE IT WAS NOT DRAINING. PER ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINANT VIA EMAIL ON (B)(6) 2019, THE CATHETER WAS IRRIGATED AND THERE WAS URINE RETURN.

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

  MAUDE report 9194262 ↗
• MalfunctionMar 21, 2019Leak/Splash

  IT WAS REPORTED THAT THE FOLEY LEAKED WHILE INSIDE OF THE PATIENT. THE PATIENT WENT TO THE HOSPITAL AND THE FOLEY WAS REPLACED.

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

  MAUDE report 8440977 ↗
• MalfunctionApr 30, 2018Leak/Splash

  IT WAS REPORTED THAT THE CATHETER LEAKED. THE LOCATION OF THE LEAK WAS UNKNOWN.

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

  MAUDE report 7473521 ↗