Bardex® I.C. Foley Catheter 0165SI12Recalls & reported problems

Summary

The FDA's MAUDE database contains 149 adverse event reports that list this exact device (DI 00801741016738), received between Apr 19, 2017 and Jul 28, 2026 — classified as 4 injuries, 145 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (25 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 25 most recent of 149 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026Fluid/Blood Leak; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50056922 ↗
• MalfunctionJul 6, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER CAME OUT IMMEDIATELY AFTER BEING PLACED IN THE OPERATING ROOM. THERE WAS A PINHOLE IN THE BALLOON PART. NO PART OF THE BALLOON REMAINED IN THE BLADDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25719845 ↗
• MalfunctionNov 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT, DURING PLACEMENT, THE FOLEY CATHETER BALLOON CUFF WAS CHECKED PREOPERATIVELY AND FOUND TO BE NORMAL. THERE WERE NO ABNORMALITIES WITH INSERTION. THE OPERATION WAS PERFORMED IN THE PRONE POSITION. THE PATIENT WAS REPOSITIONED AFTER THE OPERATION AND THERE WAS NO PARTICULAR TENSION ON THE BALLOON. HOWEVER, THE BALLOON WAS DISCOVERED RUPTURED AND DETACHED. THE LOT NUMBER FOR THIS PRODUCT WAS MYJY6278.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23494846 ↗
• MalfunctionOct 30, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING PRETESTING, IT TOOK A CONSIDERABLE AMOUNT OF TIME TO DRAIN THE WATER FROM THE FOLEY CATHETER. ALL WAS DRAINED AFTER 30 MINUTES WAS SPENT. MEDICON SYRINGE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23427666 ↗
• MalfunctionOct 23, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT STERILE WATER DID NOT ENTER INTO FOLEY CATHETER DURING PRE-TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369710 ↗
• MalfunctionOct 23, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT IMMEDIATELY AFTER THE FOLEY CATHETER INSERTION TRIED TO INJECT STERILE WATER, BUT THERE WAS STRONG RESISTANCE, AND WAS UNABLE TO INJECT. THEN REMOVED THE CATHETER AND INJECTED STERILE WATER EXTERNALLY, BUT THE BALLOON WAS INFLATED ON ONE SIDE AND WAS UNABLE TO DRAIN THE WATER AT THAT TIME. IT WAS NOW DEFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369521 ↗
• MalfunctionOct 21, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING FOLEY CATHETER BALLOON CHECK, STERILIZED WATER WAS INJECTED AND WHEN ATTEMPTED TO DRAIN BUT FAILED, SO USE WAS SUSPENDED. CURRENTLY DRAINING PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23352138 ↗
• MalfunctionOct 21, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE FOLEY CATHETER BALLOON CHECK, TRIED TO INJECT STERILE WATER AND DRAIN THE WATER, BUT IT DIDN'T DRAIN, SO REFRAINED FROM USING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347028 ↗
• MalfunctionOct 17, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT BEFORE USE WHEN WATER WAS INJECTED, A HOLE OPENED IN THE VICINITY OF THE BALLOON AND WATER LEAKED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23327548 ↗
• MalfunctionOct 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED OF THE FOLEY CATHETER AND WAS REMOVED SPONTANEOUSLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301760 ↗
• MalfunctionOct 15, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT BEFORE USE THERE WAS WATER LEAKAGE FROM THE Y-BRANCH OF THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300889 ↗
• MalfunctionOct 15, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT STERILE WATER DID NOT COME OUT FROM FOLEY CATHETER DURING THE PRE-TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23299520 ↗
• MalfunctionOct 15, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING PRETESTING, THEY WERE UNABLE TO DRAIN ANY WATER FROM THE FOLEY CATHETER. MEDICON SYRINGE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279393 ↗
• MalfunctionOct 1, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING PRE-TESTING, STERILE WATER LEAKED FROM THE FOLEY CATHETER BIFURCATED BRANCH. SO THE USE WAS SUSPENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23191023 ↗
• MalfunctionSep 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT FOLEY CATHETER WAS NOT NORMAL YELLOW COLOR SCUFFS IN BROWN CATHETER DID NOT APPEAR STERILE TIP WHERE DRAINAGE HOLES ARE WERE THIN AND DEFORMED THE INITIAL CATHETER BALLOON EXPLODED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23076072 ↗
• MalfunctionSep 17, 2025Material Discolored; Device Contamination with Chemical or Other Material; Material Discolored; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOLEY CATHETER WAS NOT NORMAL YELLOW COLOR SCUFFS IN BROWN CATHETER DID NOT APPEAR STERILE TIP WHERE DRAINAGE HOLES ARE WERE THIN AND DEFORMED THE INITIAL CATHETER BALLOON EXPLODED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23076053 ↗
• MalfunctionSep 17, 2025Material Twisted/Bent; Component Misassembled; Material Twisted/Bent; Component Misassembled

  IT WAS REPORTED THAT FOLEY CATHETER WAS NOT NORMAL YELLOW COLOR SCUFFS IN BROWN CATHETER DID NOT APPEAR STERILE TIP WHERE DRAINAGE HOLES ARE WERE THIN AND DEFORMED THE INITIAL CATHETER BALLOON EXPLODED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23075905 ↗
• MalfunctionJun 24, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT ABOUT 3CC OF STERILE WATER REMAINED DURING THE TEST. EVEN AFTER REINSERTING THE SYRINGE, THE STERILE WATER DID NOT RETURN FROM THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322150 ↗
• MalfunctionJun 24, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING PRETEST, FOLEY CATHETER BULGING WAS CONFIRMED. AFTER THAT, STERILE WATER WAS DRAINED, BUT THE BULGE DID NOT RETURN COMPLETELY, SO THEY REFRAINED FROM USING IT. THEY DID NOT REMEMBER EXACTLY HOW MANY CC DID NOT RETURN. IT WAS NOT COMPLETELY DRAINED, SO IT WAS UNCLEAR HOW MANY SECONDS IT TOOK. MEDICON SYRINGE WAS USED. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 12JUN2025, STATED THAT DURING PRETEST, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320081 ↗
• MalfunctionJun 12, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING PRETEST, UNABLE TO DRAIN THE WATER FROM THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195111 ↗
• MalfunctionJun 11, 2025Material Fragmentation; Material Rupture; Material Fragmentation; Material Rupture

  IT WAS REPORTED THAT FOLEY CATHETER GOT BROKEN. THE CATHETER WAS INSERTED ON (B)(6), BUT IT BROKE (SEPARATED) ON MAY 21 AND WAS SPONTANEOUSLY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22183873 ↗
• MalfunctionApr 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS PLACED FOR CATHETERIZATION. AFTER THE EXAMINATION, WHEN RETURNING TO THE ROOM, IT WAS DISCOVERED THAT THE FOLEY CATHETER BALLOON HAD NATURALLY BEEN REMOVED DUE TO BREAKAGE. NATURAL REMOVAL DUE TO BREAKAGE OF THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934516 ↗
• MalfunctionApr 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT STERILE WATER LEAKED FROM THE FOLEY CATHETER. THE BALLOON WAS INSERTED IN THE OPERATING ROOM, BUT WATER COULD NOT BE REMOVED AFTER THE OPERATION, AND DAMAGE TO THE FOLEY CATHETER BALLOON WAS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21840857 ↗
• MalfunctionMar 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON HAD RUPTURED A FEW DAYS AFTER IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21687819 ↗
• MalfunctionMar 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE DURING PLACEMENT, TWO CASES OF FOLEY CATHETER BALLOON BREAKAGE OCCURRED DURING PLACEMENT IN PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643110 ↗