Bardex® I.C. Foley Catheter 0165SI18Recalls & reported problems

Summary

The FDA's MAUDE database contains 181 adverse event reports that list this exact device (DI 00801741016769), received between Aug 14, 2017 and Sep 28, 2026 — classified as 21 injuries, 160 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (33 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 181 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917213 ↗
• MalfunctionSep 14, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50765280 ↗
• MalfunctionSep 11, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736904 ↗
• MalfunctionAug 31, 2026Patient Device Interaction Problem

  Patient problems: Malaise

  MAUDE report 50522635 ↗
• MalfunctionMar 10, 2026Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT THE ITEM HAD LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24565049 ↗
• MalfunctionNov 7, 2025Material Protrusion/Extrusion; Material Twisted/Bent; Material Protrusion/Extrusion; Material Twisted/Bent

  IT WAS REPORTED THAT THE CATHETER HAD A BULGE. THE CATHETER HAD DEFORMATION, SO ITS USE WAS AVOIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497749 ↗
• MalfunctionOct 29, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS SPONTANEOUSLY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415238 ↗
• MalfunctionOct 24, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A FOLEY CATHETER HAD BEEN PLACED FOR URINARY CATHETERIZATION IN SOUTH WARD 3, BUT IT WAS REMOVED NATURALLY, AND UPON EXAMINATION, A PINHOLE WAS FOUND IN THE BALLOON PART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23380638 ↗
• MalfunctionOct 22, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT FOLEY CATHETER HAD DIFFICULTY IN DRAINING WATER DURING PRE-TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357710 ↗
• MalfunctionOct 6, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PT SAID THE TIP BENT ON FOLEY MAKING THEM UNUSABLE. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23222617 ↗
• MalfunctionOct 3, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT DURING PRE-TEST, FOLEY CATHETER VALVE CAME OFF WHEN SYRINGE WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23210332 ↗
• MalfunctionJul 25, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT, DURING PLACEMENT OF THE FOLEY CATHETER, STERILE WATER WAS UNABLE TO DRAIN. HENCE, WATER EXTRACTED USING BURST METHOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22610044 ↗
• MalfunctionJul 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT URINE LEAKAGE OCCURRED FROM THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609435 ↗
• MalfunctionJul 24, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE VALVE OF THE FOLEY CATHETER WAS DETACHED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588010 ↗
• MalfunctionJul 14, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THE PATIENT STATED THAT THIS MORNING WHEN SHE WOKE UP THE FOLEY FELL OUT AND SHE HAD TO REPLACE. PATIENT STATED THAT THE BALLOON DID NOT INFLATE PROPERLY WHEN INSERTED. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494716 ↗
• MalfunctionJul 11, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT ON 02JUL THE FOLEY CATHETER WAS INSERTED FOR CATHETER REPLACEMENT. IT WAS CHECKED WITH A PRE-TEST BEFORE INSERTION AND LEFT IN PLACE. THERE WAS NO RESISTANCE TO INJECTING OR DRAINING WATER DURING THE PRE-TEST, SO IT WAS USED. ON 07JUL THEY TRIED TO REMOVE IT, BUT THERE WAS RESISTANCE AND THEY WERE UNABLE TO DRAIN THE WATER. WHEN WE TRIED TO DRAIN THE WATER, THE AREA AROUND THE FUNNEL WAS DENTED AND THERE WAS STRONG RESISTANCE AND THEY WERE UNABLE TO DRAIN THE WATER. THEY HAD NO CHOICE BUT TO CUT THE SHAFT, INJECT AN ADDITIONAL 100CC OF WATER WITH A SYRINGE, BURST THE BALLOON, AND THEN REMOVED IT. THERE WERE TWO OTHER CASES OF DIFFICULTY IN DRAINING WATER WITH THE SAME LOT IN MAY. AS THE IN-HOSPITAL DISTRIBUTION STOCK WAS THE SAME LOT AS THE DEFECTIVE PRODUCT AT THE TIME, WE REQUESTED THAT ALL 16 UNITS BE REPLACED. WE HAD COLLECTED THEM AND WOULD SEND THEM TOGETHER. ONE DEFECTIVE UNIT + 16 UNITS FROM THE SAME LOT WERE COLLECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478970 ↗
• MalfunctionJul 1, 2025Material Rupture; Material Rupture

  IT WAS REPORTED PATIENT SAID THE BALLOON ON THE FOLEY BURST. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22374311 ↗
• MalfunctionJun 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 10ML OF FIXED WATER WAS INJECTED. PALE BLOOD WAS DISCHARGED FROM URINE. THE PATIENT DID NOT LIKE THE CATHETER BEING FIXED, SO REHABILITATION PANTS WERE PUT ON WITHOUT FIXING IT. THE PATIENT WAS INFORMED THAT THE CATHETER HAD CAME OUT WHEN STRAINING TO DEFECATE AND THE CATHETER WAS HANDED BACK WITH THE FIXED WATER STILL INFLATED. UPON CLOSER INSPECTION, ONE SIDE OF THE FOLEY CATHETER WAS BULGING, AND IT WAS POINTED OUT THAT THAT MAY HAD BEEN THE CAUSE . NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Hematuria

  MAUDE report 22212803 ↗
• MalfunctionJun 11, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY IN REMOVING THE FOLEY CATHETER WHEN THEY TRIED TO REMOVE IT ONE WEEK AFTER ITS IMPLANTATION. IN THIS CASE, A PATIENT WITH A SPINAL INJURY HAD DIFFICULTY REMOVING WATER WHEN THEY ATTEMPTED TO REMOVE IT FOR REPLACEMENT AFTER 7 DAYS OF IMPLANTATION. THE PATIENT SAID THAT WATER DID NOT DRAIN OUT EVEN AFTER THE SHAFT WAS CUT. THE PATIENT WAS OPERATED BY AN EXPERIENCED NURSE, WHO HAD NEVER APPLIED EXCESSIVE NEGATIVE PRESSURE. THE PATIENT SEEMED TO HAD NO PAIN BECAUSE THEY WAS A FEMALE SPINAL CORD INJURY PATIENT, AND IT SEEMED THAT THEY WAS FORCIBLY PULLED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186306 ↗
• MalfunctionJun 11, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT WHEN THEY TRIED TO REMOVE IT AFTER ONE WEEK OF DETENTION, IT BECAME DIFFICULT TO REMOVE THE WATER FROM THE FOLEY CATHETER. NOT IN KIND. THE CATHETER WAS PLACED IN A PATIENT WITH A SPINAL INJURY FOR 7 DAYS, AND WHEN THEY TRIED TO REMOVE THE WATER FOR REPLACEMENT, IT BECAME DIFFICULT TO DRAIN THE WATER. EVEN IF THE SHAFT WAS CUT, THE WATER DID NOT COME OUT. IT WAS OPERATED BY A VETERAN NURSE, AND THEY HAD NEVER APPLIED UNREASONABLE NEGATIVE PRESSURE UNTIL NOW. IT SEEMS THAT THERE IS NO PAIN BECAUSE IT WAS A FEMALE SPINAL INJURY PATIENT, AND IT SEEMS THAT IT WAS FORCIBLY PULLED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22185056 ↗
• MalfunctionJun 11, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE AND CHECKING THE PRODUCT, THE INFLATION VALVE OF THE FOLEY CATHETER WAS DISCONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22183898 ↗
• MalfunctionMay 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PATIENT WAS HAVING PAIN AND DISCOMFORT WITH THE FOLEY CATHETER THEY RECEIVED THIS MONTH. PATIENT HAS HAD IT IN FOR A LITTLE OVER A WEAK AND NOW THERE WAS SOME SORT OF FLUID OOZING FROM THE CATHETER SITE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 22105233 ↗
• MalfunctionMay 28, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOON ON CATHETER WAS FAILED. DEFLATED IN PATIENT AND CATHETER FELL OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095792 ↗
• InjuryMay 21, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT ON (B)(6) 2025, THE FOLEY CATHETER WAS PLACED. ON (B)(6) 2025, THE BALLOON FIXATION MADE IT DIFFICULT TO DRAIN THE WATER, MAKING THE REMOVAL DIFFICULT. THIS WAS A REPORT ON THE PROCEDURE CARRIED OUT AT THE NEARBY (B)(6) HOSPITAL AFTER THE BALLOON WAS PLACED AT (B)(6) HOSPITAL AND THE WATER COULD NOT BE REMOVED UPON REMOVAL. AS PER ADDITIONAL INFORMATION RECEIVED ON 09MAY2025, THE BALLOON PUFF WAS PARTIALLY RAISED ON THE ULTRASOUND AND COULD NOT BE DEFLATED EVEN AFTER CUFF WASHING. PERCUTANEOUS PUNCTURE WAS ALSO ATTEMPTED BUT WAS DIFFICULT, AND IT WAS FINALLY REMOVED AFTER SEVERAL WASHES. WHEN THE CUFF WAS CUT AND CHECKED, IT APPEARED THAT THE LUMEN OF THE CUFF HAD DETACHED, AND THE FALSE LUMEN SIDE HAD STOPPED CONTRACTING. THE ALTERNATIVE CATHETER PLACEMENT ITSELF WAS PERFORMED WITHOUT ANY PROBLEMS. AN 18FR SILICONE BALLOON WAS PLACED, AND ALTHOUGH THERE WAS MILD HEMATURIA, THE HOSPITAL BELIEVES THAT THIS WAS NOT CLINICALLY SIGNIFICANT. ANTIBIOTICS WILL BE ADMINISTERED FOR A FEW DAYS.

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

  MAUDE report 22059896 ↗
• MalfunctionMay 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE FOLEY CATHETER COME OUT ON ITS OWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22053991 ↗