Bardex® I.C. Carson Model Coude Tip Foley Catheter 0168SI16Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00801741016967), received between Aug 5, 2018 and Aug 31, 2026 — classified as 12 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Inflation Problem; Dent in Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50522637 ↗
• InjuryNov 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT CAME BACK TO THE EMERGENCY DEPARTMENT BECAUSE THEIR FOLEY FELL OUT. THEY HAD PICTURES OF THE CATHETER IT LOOKED AS THOUGH THE BALLOON JUST BURST. THEY ALSO HAD PICTURES THE PACKAGING AND LOT NUMBER IN THE FORM. THEY SENT THEM A TASK. UNEXPECTED MEDICAL INTERVENTION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23541933 ↗
• InjuryNov 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE JUST SAW AN AWARE 230007 FROM (B)(6) HOSPITAL WHERE A PATIENT CAME BACK TO THE EMERGENCY DEPARTMENT BECAUSE THE FOLEY ¿FELL OUT¿. PATIENT RETURNED TO THE EMERGENCY DEPARTMENT AFTER INDWELLING URETHRAL CATHETER "FELL OUT". ON ARRIVAL CATHETER NO LONGER IN PLACE. PATIENT RETURNED HOME AND WHEN GETTING OUT OF THE CAR REPORTS NOTICED THAT HIS PANTS WERE GETTING WET. SEE ATTACHMENTS FOR THE CONDITION OF FOLEY CATHETER. THEY HAVE PICTURES OF THE CATHETER IT LOOKS AS THOUGH THE BALLOON JUST BURST. THEY ALSO HAVE PICTURED THE PACKAGING AND LOT NUMBER IN THE FORM.

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

  MAUDE report 23518897 ↗
• MalfunctionAug 25, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE AIDE WENT TO DO FOLEY CARE ON PATIENT AND DISCOVERED FOLEY WAS NO LONGER IN PATIENT. BALLOON WAS NOT INFLATED. DISCOVERED BALLOON SYRINGE CONNECTION PIECE WAS MISSING FROM FOLEY. FOUND PIECE IN BED UNDER PATIENT. UNSURE HOW CONNECTOR BECAME DISCONNECTED FROM FOLEY. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 27AUG2025, IT WAS REPORTED THAT NO SAMPLE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22887588 ↗
• InjuryJun 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT UNDERGOING C5 GEMZAR/TAXOTERE BLADDER INSTILLATION HAD A FOLEY CATHETER INSERTED WITHOUT ISSUES. AFTER ADMINISTERING GEMZAR AND TAXOTERE, THE PATIENT HEARD A POP AND NEEDED A BOWEL MOVEMENT. WHILE IN THE RESTROOM, ANOTHER POP WAS HEARD, AND THE FOLEY CATHETER CAME OUT AS THE PATIENT URINATED. THE PATIENT REPORTED NO PAIN OR BLOOD IN THE URINE. A STAT BLADDER ULTRASOUND WAS ORDERED, AND A CYSTOSCOPY THE NEXT DAY REMOVED THE FOLEY BALLOON FOREIGN BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22320007 ↗
• InjuryJun 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THIS PATIENT WAS NOTED TO HAVE A RETAINED FOREIGN BODY. THEY SUSPECTED TO BE A URINARY FOLEY CATHETER BALLOON FRAGMENT AFTER CHEMOTHERAPY BLADDER INSTILLATION WHICH WAS RESULTING IN FURTHER FOLLOW-UP WITH UROLOGY FOR REMOVAL. THE DEVICE WAS RETAINED AND EVALUATED BY THE DEPARTMENT LEADER. THE FINDINGS PRESENT CONCERNS FOR A LIKELY INDWELLING URINARY CATHETER PRODUCT MALFUNCTION. THE SUPPLY CHAIN SERVICES MANAGER WAS WORKING WITH THE LEADER ON INITIAL IMMEDIATE STEPS. LOT#NGJX4559 AND LOT#NGJY3539.

  Patient problems: Foreign Body In Patient

  MAUDE report 22194628 ↗
• InjuryJun 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THIS PATIENT WAS NOTED TO HAVE A RETAINED FOREIGN BODY. THEY SUSPECTED TO BE A URINARY FOLEY CATHETER BALLOON FRAGMENT AFTER CHEMOTHERAPY BLADDER INSTILLATION WHICH WAS RESULTING IN FURTHER FOLLOW-UP WITH UROLOGY FOR REMOVAL. THE DEVICE WAS RETAINED AND EVALUATED BY THE DEPARTMENT LEADER. THE FINDINGS PRESENT CONCERNS FOR A LIKELY INDWELLING URINARY CATHETER PRODUCT MALFUNCTION. THE SUPPLY CHAIN SERVICES MANAGER WAS WORKING WITH THE LEADER ON INITIAL IMMEDIATE STEPS. LOT#NGJX4559 AND LOT#NGJY3539.

  Patient problems: Foreign Body In Patient

  MAUDE report 22186319 ↗
• MalfunctionJun 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PHARMACIST STATED THAT THEY USED SURESTEP FOLEY TRAY A304716A FOR CHEMOTHERAPY IN THE BLADDER. THE FOLEY CATHETER BALLOON BURST, EVEN THOUGH THEY HAVE DONE THIS PROCESS MANY TIMES BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186313 ↗
• InjuryMay 23, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE FOLEY CATHETER BROKE APART WHILE IN THE PATIENTS. NOT SURE IF THERE HAS BEEN ANY MEDICAL INTERVENTION YET. IT WAS NOTED THAT THE GIVEN LOT# WAS NGKN2100. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 06MAY2025, THE RUPTURED BALLOON PIECES WERE IN THE ANATOMIC PATHOLOGY DEPARTMENT. THESE COULD NOT BE RELEASED WITHOUT PATIENT PERMISSION. FOR PATIENT NUMBER 1 URINARY TRACT INFECTION AND FOUND ON A ROUTINE CYSTOSCOPY. FOR PATIENT NUMBER 2 UNSCHEDULED CYSTOSCOPY PERFORMED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22078278 ↗
• InjuryMay 9, 2025Material Fragmentation; Material Rupture; Material Fragmentation; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER RUPTURE OCCURRED. LATER THE BALLOONS WERE RETRIEVED BY PERFORMING A CYSTOSCOPY ON THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21993844 ↗
• InjuryMay 9, 2025Material Fragmentation; Material Rupture; Material Fragmentation; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER RUPTURE OCCURRED. THE BALLOONS WERE RETRIEVED BY PERFORMING A CYSTOSCOPY ON THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21993843 ↗
• InjuryMay 5, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE FOLEY CATHETER BROKE APART WHILE IN THE PATIENTS. NOT SURE IF THERE HAS BEEN ANY MEDICAL INTERVENTION YET. IT WAS NOTED THAT THE GIVEN LOT# WAS NGKN2100.

  Patient problems: Foreign Body In Patient; Urinary Tract Infection

  MAUDE report 21960954 ↗
• InjuryApr 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT FOLEY CATHETER BALLOON FAILURE CAUSED A RETAINED FOLEY BALLOON IN THE BLADDER AND LEFT PART OF THE FOLEY BALLOON IN A PATIENT UPON REMOVAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 21839173 ↗
• MalfunctionApr 8, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT TIP OF THE FOLEY CATHETER FELL OFF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21797807 ↗
• MalfunctionOct 28, 2024Wrong Label; Wrong Label

  IT WAS REPORTED THAT THEY SEE FROM THE PICTURE THAT THE UNKNOWN COUDE FOLEYS WERE NOT THE INFECTION CONTROL, BUT THEY WERE LABELED INFECTION CONTROL. THEY WERE THE SAME COLOR AS THE STANDARD BARDEX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20547041 ↗
• MalfunctionOct 22, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT HAD 2 DEFECTIVE CATHETERS, THE FOLEY BULB FAILED ONCE WHILE THEY WERE IN THE BED AND THE OTHER ONE WHILE THEY WERE ON THEIR WAY TO THE GROCERY STORE. THEY SAID THE URINE WAS ALL OVER THE PLACE. THE REPRESENTATIVE ADVISED TO CONTACT AT THE TIME OF INCIDENT AND TO REPLACE ONE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506090 ↗
• MalfunctionOct 14, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INSTILLATION PORT BROKE OFF AFTER PLACEMENT OF THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20438924 ↗
• MalfunctionMay 10, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WOULD NOT INFLATE AND KEPT LEAKING WHEN STERILE WATER WAS INSERTED, SO THE PATIENT NEEDED A NEW FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19287080 ↗
• MalfunctionDec 1, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT CUSTOMER HAD 2 VETERAN ICU REGISTER NURSES THAT WERE GOING TO INSERT A FOLEY CATHETER. THEY WERE TOLD NOT TO, BUT THEY ALWAYS TESTED THE BALLOONS STILL ANYWAY. THEY HAD 3 FOLEY CATHETERS WHERE THE BALLOON WOULD NOT DEFLATE. SEVERAL HOURS LATER THEY WERE ABLE TO DEFLATE THEM, BUT MULTIPLE PEOPLE AT THE TIME WERE UNABLE. TWO HAD THE LOT NUMBER 2PY008. ONE HAD LOT NUMBER NGHR1734.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18248138 ↗
• InjuryNov 9, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT RUBBER TUBING SNAPPED OR BROKE OFF WHEN PATIENT PULLED ON IT AND PART OF FOLEY CATHETER REMAINED IN PATIENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18104234 ↗
• MalfunctionSep 13, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT REGISTER NURSE IN THE ROOM STATED FOLEY CATHETER DID NOT HAVE A HOLE IN IT. CUSTOMER ALSO STATED THAT IT WAS A SOLID CATHETER WITH NO DRAINAGE HOLES IN IT. THE OTHER ONE THEY HAD OF THAT SAME LOT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17738183 ↗
• MalfunctionJan 13, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS LEAKING DUE TO TWO HOLES IN THE TUBE SO THEY HAD TO GO TO EMERGENCY ROOM TO GET IT REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16156716 ↗
• MalfunctionAug 17, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE URINE STARTED TO COME OUT OF THE BALLOON PORT AND THE REGULAR CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12331143 ↗
• MalfunctionJun 4, 2020Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A CUT ON THE CATHETER THAT LEAKED NEAR THE PORT.

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

  MAUDE report 10121379 ↗
• InjuryJan 31, 2020Deflation Problem; Difficult to Remove; Deflation Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RASH IN THE GROIN AND AXILLA AFTER THE URINARY CATHETER WAS PLACED. THE CATHETER COULD NOT BE REMOVED MANUALLY BY THE NURSE, SO UROLOGY HAD TO BE CALLED IN FOR ASSISTANCE. IT WAS LATER REPORTED THAT THE UROLOGIST MADE MULTIPLE ATTEMPTS TO REMOVE THE BALLOON, WHICH INCLUDED AN ATTEMPT TO REMOVAL FLUID, WITH NO RETURN, CUT THE CATHETER PROXIMAL TO THE Y, WITH NO RELEASE. A GUIDE WIRE WAS THEN INSERTED THROUGH THE INFLATION CHANNEL, WITH NO SUCCESS. SUBSEQUENTLY, THE GUIDE WIRE WAS USED TO PLACE A SMALL HOLE IN THE BALLOON. THE UROLOGIST WAS THEN ABLE TO DEFLATE THE BALLOON WITH GENTLE TRACTION ON THE BLADDER NECK.

  Patient problems: Patient Problem/Medical Problem; Rash

  MAUDE report 9654837 ↗