Bardex® I.C. Foley Catheter 0166SI16Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741016844), received between Nov 6, 2019 and Dec 2, 2025 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT, AT THE CATHETER TIP THAT WENT INTO BLADDER IT HAVE 2 ISLETS TO ALLOW THE FLUID TO GO INTO THE FOLEY CATHETER. THAT WAS RIGHT UP AT THE TIP OF THE CATHETER. IT WAS ABOUT ROUGHLY 5 MILLIMETRES FROM THE END AND HAS A SLIT OF ABOUT 5 MILLIMETRES EITHER SIDE OF THAT. THEN BLOW COUPLE OF ML, INTO THE BALLOON AND WHEN THE BALLOON BLOWN UP, THE CATHETER TIP'S ONLY ABOUT A CENTIMETRE LONG THAT STICKS OUT THE END, WHICH IN TURN STOP IT FROM GOING INTO THE WALL OF YOUR CATHETER AND BLOCKING IT UP. THE ISLET, THE FLUID'S SUPPOSED TO COME AT THE BOTTOM & AT THE TOP OF THE CHIP. ONE'S RIGHT UP AT THE END OF THE CHIP, AND THE OTHER ONE'S ABOUT ANOTHER CENTIMETRE DOWN THE SIDE. THEREFORE, THE BALLOON THEN BECAME FURTHER DOWN THE TIP. SO THE TIPS INSIDE THE BLADDER WAS FLOPPING AROUND OF ABOUT 4 CENTIMETRES LONG, WHICH IN TURN JUST CRASHES INTO THE WALL OF BLADDER AND BLOCKS UP, AND IT GOT DYSREFLEXIA AND CAUSED THE CHRONIC DYSREFLEXIA, WHICH TURN RAISES CUSTOMER'S BLOOD PRESSURE TO ABOUT 230, WHICH IN TURN INTO A HEART FAILURE SITUATION. SO PATIENT COULD NOT USE THESE CATHETERS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Heart Failure/Congestive Heart Failure

  MAUDE report 23697036 ↗
• MalfunctionJun 19, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE REPRESENTATIVE WANTED TO ENQUIRE AS TO WHETHER OR NOT THERE HAD BEEN ANY CHANGES TO THE DESIGN OF THE BARDEX IC CATHETERS. A CUSTOMER RECENTLY PURCHASED A LARGE AMOUNT AND HAD NOTED THAT THE EYELET WAS TOO LOW ON THE CATHETER TO BE USABLE, AS COMPARED TO HIGHER UP. THE CUSTOMER PURCHASED THE 0166SI16 16FG SIZING. WHILE THIS MIGHT JUST BE A DESIGN DIFFERENCE BETWEEN BARDEX AND OTHER STYLES OF CATHETERS, THE REPRESENTATIVE WOULD LIKE TO CONFIRM THAT THERE WAS NO FAULT OR DESIGN CHANGE, TO ASSIST THE CUSTOMER SERVICE TEAM TO RESOLVE.

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

  MAUDE report 17151764 ↗
• MalfunctionJul 12, 2022Burst Container or Vessel; Material Rupture; Burst Container or Vessel; Material Rupture

  IT WAS REPORTED THAT THE 24FR SILICONE FOLEY CATHETER HAD RUPTURED . AS PER SAMPLE RECEIVED ON (B)(6) 2022, IT WAS NOTED THAT THE LATEX FOLEY CATHETER WITH MATERIAL # 0166SI16 WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14991103 ↗
• MalfunctionSep 7, 2021Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT FOR THE LAST NINE MONTHS, THE CATHETERS HAD BEEN GETTING STOPPED UP AND THE TIP EYELETS WERE CRUSTED WITH A GRITTY SANDY SUBSTANCE ALMOST LIKE IT WAS DISINTEGRATING WHILE IN USE. IT WAS STATED THAT THEY WERE ALTERNATING WITH GENTAMYCIN AND ACIDIC ACID FOR FLUSHING AND THEY COULD NOT FLUSH THE CATHETER. IT WAS ALSO STATED THAT THREE CATHETERS WOULD NOT DEFLATE AFTER USE. IT WAS NOTED THAT THE PATIENT HAD NO MEDICAL CONDITION IDENTIFIED THAT WOULD CAUSE THIS TYPE OF ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12433847 ↗
• MalfunctionSep 7, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOR THE LAST NINE MONTHS, THE CATHETERS HAD BEEN GETTING STOPPED UP AND THE TIP EYELETS WERE CRUSTED WITH A GRITTY SANDY SUBSTANCE ALMOST LIKE IT WAS DISINTEGRATING WHILE IN USE. IT WAS STATED THAT THEY WERE ALTERNATING WITH GENTAMYCIN AND ACIDIC ACID FOR FLUSHING AND THEY COULD NOT FLUSH THE CATHETER. IT WAS ALSO STATED THAT THREE CATHETERS WOULD NOT DEFLATE AFTER USE. IT WAS NOTED THAT THE PATIENT HAD NO MEDICAL CONDITION IDENTIFIED THAT WOULD CAUSE THIS TYPE OF ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12433844 ↗
• MalfunctionSep 7, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT FOR THE LAST NINE MONTHS, THE CATHETERS HAD BEEN GETTING STOPPED UP AND THE TIP EYELETS WERE CRUSTED WITH A GRITTY SANDY SUBSTANCE ALMOST LIKE IT WAS DISINTEGRATING WHILE IN USE. IT WAS STATED THAT THEY WERE ALTERNATING WITH GENTAMYCIN AND ACIDIC ACID FOR FLUSHING AND THEY COULD NOT FLUSH THE CATHETER. IT WAS ALSO STATED THAT THREE CATHETERS WOULD NOT DEFLATE AFTER USE. IT WAS NOTED THAT THE PATIENT HAD NO MEDICAL CONDITION IDENTIFIED THAT WOULD CAUSE THIS TYPE OF ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12433737 ↗
• MalfunctionMar 17, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT COULD HARDLY USE THE CATHETER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11507148 ↗
• MalfunctionDec 30, 2020Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE PATIENT USED A FOLEY FOR SUPRA-PUBIC CATHETER. STATED PATIENT HAD A ISSUE WITH BALLOON DEFLATING AND THE CATHETER CAME OUT. PATIENT STATED THAT ONE TIME THEY REFILLED THE BALLOON AND DID NOT SEE ANY LEAKING. WHEN THE CATHETER FELL OUT, THE BALLOON WAS DEFLATED, SO THE LEAK MIGHT BE EXTREMELY STRONG. PATIENT STATED LAST NIGHT , IT DEFLATED ENOUGH TO FALL OUT AFTER 2 HOURS OF IT BEING PUT IT. PATIENT REFILLED THE BALLOON AT AROUND 8PM AND IT FELL OUT AGAIN TODAY AT AROUND 2PM OR 3PM. PATIENT STATED IT HAD BEEN HAPPENING WITH THE LAST ORDER OF CATHETERS THAT RECEIVED. PATIENT WENT THROUGH ALL 3 FROM THE LAST ORDER.

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

  MAUDE report 11097890 ↗
• MalfunctionDec 9, 2020Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE FOLEY CATHETER FAILED AND IT WAS DEFECTIVE. STATED THAT ONE OF THE FOLEY BALLOONS WOULD NOT INFLATE AND SO PATIENT THREW THE CATHETER AWAY. ALSO WASTED ONE OF INSERTION TRAYS DUE TO THIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10980137 ↗
• InjuryMay 5, 2020Biocompatibility; Patient-Device Incompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT SAID SHE EXPERIENCED WORSE BURNING AND BRUISING IN HER BLADDER WITH THIS CATHETER THAN WITH THE LAST ONE. IT IS CURRENTLY UNKNOWN IF THE PATIENT RECEIVED INTERVENTION.

  Patient problems: Bruise/Contusion; Burning Sensation; Patient Problem/Medical Problem

  MAUDE report 10025023 ↗
• MalfunctionFeb 19, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THE CATHETER RUPTURED WHILE BEING USED FOR CERVICAL DILATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9727011 ↗
• MalfunctionNov 6, 2019Break; Unsealed Device Packaging; Break

  IT WAS REPORTED THAT THE INNER PACKAGING WAS ALREADY OPENED UPON RECEIPT OF THE FOLEY CATHETER. PER ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINANT VIA EMAIL ON 28OCT2019, THE SEAL LOOKED LIKE IT HAD BEEN CUT. THE COMPLAINANT NOTED THAT THE OUTSIDE PACKAGE WAS OPENED AND THE NURSE GRABBED THE BLUE STERILE PACKAGE AND THE FOLEY CATHETER FELL OUT OF THE BOTTOM.

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

  MAUDE report 9286102 ↗