Bardex® Lubricath® Foley Catheter Creevy Model 01267520Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00801741018800), received between Feb 12, 2018 and Mar 30, 2026 — classified as 47 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (8 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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Complete Blockage

  IT WAS REPORTED THAT FOLEY CATHETER WAS DAMAGED AS PRESENT A MALFUNCTION IN THE THIRD IRRIGATION CHANNEL. THE CHANNEL APPEARS TO BE OBSTRUCTED.

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

  MAUDE report 24719353 ↗
• MalfunctionMar 3, 2026Material Puncture/Hole

  IT WAS REPORTED THAT AFTER USE, THE FOLEY CATHETER FALLS OUT OF THE PATIENT BECAUSE OF LEAKING BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500458 ↗
• MalfunctionNov 7, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT, BALLON DEFORMATION OCCURRED OF THE FOLEY CATHETER BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23495278 ↗
• MalfunctionSep 26, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER HAD LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23155125 ↗
• MalfunctionJun 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD LEAKAGE DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338275 ↗
• MalfunctionApr 25, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT MISSING ACCESSORIES. NO WATER STOP VALVE AT THE WATER INJECTION POINT OF THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909670 ↗
• MalfunctionApr 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON RUPTURED AND LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873628 ↗
• MalfunctionDec 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER WAS LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036934 ↗
• MalfunctionJun 18, 2024Inflation Problem; Failure to Infuse; Inflation Problem; Failure to Infuse

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON COULD NOT BE INFLATED OR DISCHARGED DURING A PRETEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19557144 ↗
• MalfunctionMay 16, 2024Inability to Irrigate; Inability to Irrigate

  IT WAS REPORTED THAT BY USING THE FOLEY CATHETER, IRRIGATION CANNOT BE FILLED WITH WATER. THEY REPLACED A NEW ONE. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON (B)(6) 2024, STATED THAT THEY CANNOT PERFORM IRRIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19331209 ↗
• MalfunctionApr 8, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT WATER IN THE FOLEY CATHETER COULD NOT BE DRAINED. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 01APR2024, THE WATER COULD NOT BE DRAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19060587 ↗
• MalfunctionJan 22, 2024Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT WATER CANNOT BE PENETRATED INTO THE BALLOON OF FOLEY CATHETER BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18553361 ↗
• MalfunctionJan 12, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT WHEN THE FOLEY CATHETER WAS REMOVED, IT COULD NOT BE DRAINED, SO IT WAS CUT OFF DIRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18503569 ↗
• MalfunctionDec 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FOLEY CATHETER HAD LEAKAGE FROM PIPE WALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18329040 ↗
• MalfunctionAug 4, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17466754 ↗
• MalfunctionJul 18, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON COULD NOT DEFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17341921 ↗
• MalfunctionJun 28, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOON LEAKED AND THE FOLEY CATHETER FELL OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17215768 ↗
• MalfunctionJun 13, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT AFTER INSERTING THE FOLEY CATHETER INTO THE URETHRA, THERE WAS NO RESISTANCE WHILE INJECTING THE STERILE WATER THROUGH THE INFLATION LUMEN BUT THEN A RESISTANCE WAS FELT WHILE INJECTING THE CLEANING SOLUTION, SO THE CATHETER WAS REMOVED AND THE CLEANING SOLUTION WAS INJECTED AGAIN INTO THE IRRIGATION LUMEN AND TESTED, RESULTING IN BALLOON INFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17118632 ↗
• MalfunctionMay 19, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE VALVE GOT DISCONNECTED AND FELL OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16962599 ↗
• MalfunctionMay 12, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON HAD BURST AND DROPPED. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 03MAY2023, STATED THAT THE "BURST AND DROP" MEANT THAT "CATHETER FELL OUT AND THE BALLOON BURST".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16918365 ↗
• MalfunctionApr 28, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE WATER INJECTED INTO THE BALLOON HAS HIGH RESISTANCE DUE TO A DUST FOUND. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 14APR2023,WATER INJECTED INTO THE BALLOON HAS HIGH RESISTANCE ('DUST WAS FOUND' - THIS PART IS REDUNDANT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16831035 ↗
• MalfunctionNov 2, 2022Inability to Irrigate; Inability to Irrigate

  IT WAS REPORTED THAT THE WATER COULD NOT BE POURED INTO THE BLADDER TO FLUSH. IT WAS MENTIONED THAT THE USER CHANGED A NEW FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15713814 ↗
• MalfunctionAug 15, 2022Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS A CRACK ON THE FOLEY CATHETER TIP UPON OPENING THE PACKAGE. THE DEVICE WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15224139 ↗
• MalfunctionJul 18, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE AND CHECKING THE FOLEY CATHETER, THE PLASTIC PART OF THE FUNNEL WAS PARTIALLY CHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15043455 ↗
• MalfunctionJun 24, 2022Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT WATER LEAKED FROM THE CONNECTION OF THE INFLATION VALVE DURING THE PRETEST. THERE WAS NO BALLOON RUPTURE OR TEAR WAS FOUND AND THE PATIENT DID NOT HAVE ANY URINE STONE. PER FOLLOW UP VIA IBC ON 09JUN2022, THE CAUSE OF THE LEAK WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14801592 ↗