Bardex® I.C. Foley Catheter 0165SI22Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741016783), received between Aug 15, 2017 and Sep 14, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Partial Blockage” (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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50764426 ↗
• MalfunctionJan 21, 2026Difficult to Remove

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER HAD DIFFICULTY IN DRAINING WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24138117 ↗
• MalfunctionMay 20, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD RUST ON IT. THE PHOTOS OF THE SECOND CATHETER WERE FOUND TO BE DAMAGED. THE PACKAGING WAS ALL SEALED UP BEFORE OPENING FIRST LAYER, THEN OPENING BLUE COVER ON CATHETER. AS IF MENTIONED, WAS SECOND ONE IN A MATTER OF WEEKS AND HAD THROWN OUT FIRST ONE BUT KEPT THIS ONE TO SEND TO BARD. THE FLASH IS TURNED ON SO COULD SEE THE BROWN STUFF ALONG WITH SIZE OF HOLE. THAT'S CLEARLY BIGGER, THEY'RE STORED IN THE BEDROOM UNIT BESIDE MY BED. NO EXCESSIVE HEAT, CONDENSATION. THE SIZE OF HOLE WAS FIRST CLUE, HAD WITH FIRST FAULTY CATHETER AND THIS ONE EXACT SAME, THEN TURNED FLASH ON AND SAW HOW GROSS IT ACTUALLY WAS. THE PATIENT HAD THE TWO UNITS SINCE JANUARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054002 ↗
• MalfunctionMay 20, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD RUST ON IT. THE PHOTOS OF THE SECOND CATHETER WERE FOUND TO BE DAMAGED. THE PACKAGING WAS ALL SEALED UP BEFORE OPENING FIRST LAYER, THEN OPENING BLUE COVER ON CATHETER. AS IF MENTIONED, WAS SECOND ONE IN A MATTER OF WEEKS AND HAD THROWN OUT FIRST ONE BUT KEPT THIS ONE TO SEND TO BARD. THE FLASH IS TURNED ON SO COULD SEE THE BROWN STUFF ALONG WITH SIZE OF HOLE. THAT'S CLEARLY BIGGER, THEY'RE STORED IN THE BEDROOM UNIT BESIDE MY BED. NO EXCESSIVE HEAT, CONDENSATION. THE SIZE OF HOLE WAS FIRST CLUE, HAD WITH FIRST FAULTY CATHETER AND THIS ONE EXACT SAME, THEN TURNED FLASH ON AND SAW HOW GROSS IT ACTUALLY WAS. THE PATIENT HAD THE TWO UNITS SINCE JANUARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22053416 ↗
• MalfunctionMay 20, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD RUST ON IT. THE PHOTOS OF THE SECOND CATHETER WERE FOUND TO BE DAMAGED. THE PACKAGING WAS ALL SEALED UP BEFORE OPENING FIRST LAYER, THEN OPENING BLUE COVER ON CATHETER. AS IF MENTIONED, WAS SECOND ONE IN A MATTER OF WEEKS AND HAD THROWN OUT FIRST ONE BUT KEPT THIS ONE TO SEND TO BARD. THE FLASH IS TURNED ON SO COULD SEE THE BROWN STUFF ALONG WITH SIZE OF HOLE. THAT'S CLEARLY BIGGER, THEY'RE STORED IN THE BEDROOM UNIT BESIDE MY BED. NO EXCESSIVE HEAT, CONDENSATION. THE SIZE OF HOLE WAS FIRST CLUE, HAD WITH FIRST FAULTY CATHETER AND THIS ONE EXACT SAME, THEN TURNED FLASH ON AND SAW HOW GROSS IT ACTUALLY WAS. THE PATIENT HAD THE TWO UNITS SINCE JANUARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22053414 ↗
• MalfunctionMay 20, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD RUST ON IT. THE PHOTOS OF THE SECOND CATHETER WERE FOUND TO BE DAMAGED. THE PACKAGING WAS ALL SEALED UP BEFORE OPENING FIRST LAYER, THEN OPENING BLUE COVER ON CATHETER. AS IF MENTIONED, WAS SECOND ONE IN A MATTER OF WEEKS AND HAD THROWN OUT FIRST ONE BUT KEPT THIS ONE TO SEND TO BARD. THE FLASH IS TURNED ON SO COULD SEE THE BROWN STUFF ALONG WITH SIZE OF HOLE. THAT'S CLEARLY BIGGER, THEY'RE STORED IN THE BEDROOM UNIT BESIDE MY BED. NO EXCESSIVE HEAT, CONDENSATION. THE SIZE OF HOLE WAS FIRST CLUE, HAD WITH FIRST FAULTY CATHETER AND THIS ONE EXACT SAME, THEN TURNED FLASH ON AND SAW HOW GROSS IT ACTUALLY WAS. THE PATIENT HAD THE TWO UNITS SINCE JANUARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22052128 ↗
• MalfunctionJul 6, 2022Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE STERILIZED WATER LEAKED FROM THE INFLATION VALVE DURING PRETEST. THERE WAS NO BALLOON RUPTURE OR TEAR AND THE PATIENT DID NOT HAVE ANY URINE STONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14938306 ↗
• MalfunctionMar 17, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A CUT MARK FOUND IN THE SHAFT OF THE FOLEY CATHETER DURING PRETEST AND THE WATER LEAKED FROM THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13796252 ↗
• MalfunctionJan 28, 2022Burst Container or Vessel; Material Split, Cut or Torn; Burst Container or Vessel; Material Split, Cut or Torn

  IT WAS REPORTED THAT WATER LEAKED FROM THE FOLEY CATHETER BALLOON DURING PRETEST. IT WAS MENTIONED THAT A RUPTURE OR TEAR WAS FOUND ON THE FOLEY CATHETER BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13389209 ↗
• MalfunctionDec 12, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS REMOVED SPONTANEOUSLY. WHEN THE BALLOON PART WAS CONFIRMED, THE DISTILLED WATER WAS DRAINED. IT WAS ALSO REPORTED THAT THERE WAS NO BALLOON RUPTURE OR TEAR. AS PER FOLLOW UP INFORMATION RECEIVED ON 02DEC2021, DAMAGE TO THE CATHETER WAS UNKNOWN AND THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12981763 ↗
• MalfunctionSep 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD LEAKAGE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12505821 ↗
• MalfunctionApr 6, 2021Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER DID NOT DEFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11625146 ↗
• InjuryJan 2, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT HAD RE OCCURRING URINARY TRACT INFECTIONS. PATIENT HAD PAIN AND IRRITATION WHEN INSERTING CATHETER. DOCTOR STATED IT WAS ALL FROM USAGE OF THE CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTIONS.

  Patient problems: Irritability; Irritation; Pain; Urinary Tract Infection

  MAUDE report 11103903 ↗
• MalfunctionDec 22, 2020Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO INFLATE. IT WAS FURTHER REPORTED THAT INSTEAD OF THE BALLOON, THE SHAFT INFLATED.

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

  MAUDE report 11055933 ↗
• MalfunctionOct 9, 2020Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE FOLEY CATHETERS GOT CLOGGED UP SOMETIMES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10658697 ↗
• MalfunctionJan 28, 2020Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE FOLEY CATHETERS WERE NOT DRAINING CORRECTLY, WHICH CAUSED THE URINE TO BACK UP AND CAUSE THE PATIENT PAIN. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Pain

  MAUDE report 9638767 ↗
• MalfunctionDec 1, 2018Partial Blockage; Partial Blockage; Deflation Problem; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS URINE LEAKAGE FROM THE CATHETER AND THE USER WAS UNABLE TO DEFLATE THE BALLOON WHEN TRYING TO REPLACE THE CATHETER. THE OPERATOR CUT THE CATHETER ACCORDING TO THE INSTRUCTIONS AND USED A GUIDEWIRE, HOWEVER THE USER WAS STILL UNABLE TO DEFLATE THE BALLOON. ON THE NEXT DAY, WHEN PUSHING THE DRAINAGE LUMEN OF THE CATHETER WITH A STYLET, THE OPERATOR FELT THAT THERE WAS CALCULI IN IT, HOWEVER THE SITUATION DID NOT IMPROVE. AFTER THAT, THE USER COULD REMOVE THE CATHETER AS THE BALLOON DEFLATED. THE USER CONFIRMED THERE WAS A HOLE ON THE REMOVED BALLOON, WHICH SEEMED TO HAVE BEEN PERFORATED WITH A GUIDEWIRE ON THE DAY BEFORE.

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

  MAUDE report 8121935 ↗
• MalfunctionNov 13, 2017No Flow

  IT WAS REPORTED THAT THE CATHETER, PLACED SUPRAPUBICALLY, WOULD NOT ALLOW URINE TO DRAIN. PER FOLLOW UP WITH THE COMPLAINANT SOME PAIN WAS EXPERIENCED, HOWEVER NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Urinary Retention

  MAUDE report 7024271 ↗
• MalfunctionAug 15, 2017Partial Blockage; No Flow

  IT WAS REPORTED THAT THE SUPRAPUBIC CATHETER WAS BLOCKED AND DID NOT ALLOW URINE TO DRAIN. THE PATIENT EXPERIENCED PAIN WHICH LEAD HIM TO REMOVE THE CATHETER AND REPLACE IT WITH A NEW ONE. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: Pain; Urinary Retention

  MAUDE report 6796258 ↗