Bardex® I.C. Carson Model Coude Tip Foley Catheter 0168SI18Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741016974), received between Apr 23, 2019 and Apr 11, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Dent in Material” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT CUSTOMER STATED ITEM NUMBER 0168SI18 FOLEY BALLOON CATHETER EXPLODED ON PATIENT. PER NOTATION PATIENT ACCOUNT HAD TO GO TO THE HOSPITAL DUE TO THAT FOLEY ISSUE. UNFORTUNATELY THEY WERE UNABLE TO PROVIDE THEM WITH A LOT NUMBER FROM THE FAULTY FOLEY. THAT PRODUCT HAD BEEN DISPOSED OF BY THE HOSPITAL STUFF UNABLE TO RECOVER. THEY ALREADY CREDITED PRODUCT FOR OUR CUSTOMER.

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

  MAUDE report 21824976 ↗
• MalfunctionNov 27, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE REGISTERED NURSE PLACED FOLEY CATHETER IN EMERGENCY DEPARTMENT PATIENT. WHEN ATTEMPTING TO INFLATE THE BALLOON WITH SALINE FILLED SYRINGE, THE BALLOON HUB BROKE APART AND THE FOLEY WAS REMOVED AND A NEW FOLEY WAS PLACED IN THE PATIENT. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 04DEC2024, STATED THAT THE PRE-ATTACHED EXTENSION TUBING DISLODGED FROM THE STABILIZATION PLATFORM AFTER STARTING THE IV ON THE PATIENT. THEY WERE ABLE TO TAMPONED THE VEIN AND REMOVE THE CATHETER ASSEMBLY WITH ONLY A FEW CC BLOOD LOSS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798182 ↗
• MalfunctionAug 10, 2022Dent in Material; Dent in Material

  IT WAS REPORTED THAT THE FOLEY CATHETERS NUB IDENTIFIED NUB AS PART OF THE MOLDED CATHETER, AND IT ALLOWED HEALTH CARE PROFESSIONALS TO SEE THE TIP OF THE COUDE FOLEY. IF PATIENT COULD SEE THE NUB, THEN THE TIP WOULD BE IN THE UPWARD POSITION AND WOULD ASSIST WITH CORRECT PLACEMENT OF DEVICE SO IT WOULD NOT INTERFERE WITH THE CONNECTIONS. AFTER FURTHER REVIEW, IT WAS NOTED THAT FOLEY HAD BEEN IN PLACE SINCE 21SEP2021. IT WAS STATED THAT THE SUSPECT FOLEY MATERIAL HAD STRETCHED TO THE POINT IT WOULD NO LONGER FIT SNUGGLY ONTO URINE DRAINAGE BAG CONNECTIONS. IT WAS NOTED THAT THE CONNECTIONS WOULD NOT GET BETTER AS THE PICTURE SHOWED THE FOLEY WAS ON THE DRAINAGE BAG CONNECTION PRETTY MUCH AS FAR AS IT WOULD GONE WITHOUT ENTERING THE STATLOCK SPACE. PER ADDITIONAL INFORMATION RECEIVED WITH RETURN SAMPLE ON 08DEC2021, IT WAS STATED THAT THE CATHETER WAS SEPARATED FROM THE LEG BAG/24-DEGREE NIGHT DRAIN BAG AND CAUSED SOLING THE O BED MATTRESS AND EVERYTHING. IT WAS DISTRESSING TO CAREGIVER AND PATIENT HAD COGNITIVE LIMITATION DUE TO BRAIN TUMOR. AND CUSTOMER ASKED HOW LONG A BARD FOLEY SHOULD BE CHANGED? HOW LONG 24-DEGREE NIGHT URINE COLLECTION BAG BE USED? HOW LONG THEY SHOULD BARD L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15204878 ↗
• InjuryApr 23, 2019Patient-Device Incompatibility; Therapeutic or Diagnostic Output Failure; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE SILVER COATING ON THE CATHETER DID NOT WORK FOR THE PATIENT. REPORTEDLY, THE PATIENT ENDED UP IN THE HOSPITAL, WHERE HE WAS FOUND TO BE SEPTIC.

  Patient problems: Patient Problem/Medical Problem; Sepsis; Skin Irritation

  MAUDE report 8541771 ↗