Bardex®Lubricath® Foley Catheter Alcock Model 0134L22Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741018770), received between Oct 3, 2018 and Mar 26, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Inability to Irrigate” (3 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PLACEMENT, THEY TRIED TO INFLATE THE FOLEY CATHETER BALLOON WITH STERILE WATER, BUT IT DID NOT GO IN. THEY WAS ABLE TO INJECT SOME WATER, BUT THE AMOUNT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697041 ↗
• MalfunctionFeb 20, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THIS WAS A WATER LEAK. WHEN SALINE WAS INJECTED, A LEAK OCCURRED FROM THE IRRIGATION LUMEN OF THE FOLEY CATHETER. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 06FEB2025, CUSTOMER CONFIRMED THAT PATIENT INVOLVED BUT NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421477 ↗
• MalfunctionOct 22, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE STERILE WATER LEAKED FROM THE BALLOON AREA OF THE FOLEY CATHETER DURING A PRETEST. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 10OCT2024, STATED THAT CUSTOMER CONFIRMED THAT PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20509279 ↗
• MalfunctionFeb 16, 2024Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED THAT WATER LEAKED THROUGH A HOLE IN THE TIP OF THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18719892 ↗
• MalfunctionSep 21, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A HARD-PLASTIC PIECE NOTED TO BE INSIDE LUMEN OF FOLEY CATHETER AND IT WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15461927 ↗
• MalfunctionAug 18, 2022Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT IT WAS DIFFICULT TO INJECT STERILE WATER INTO THE FOLEY CATHETER BALLOON. IT WAS STATED THAT HEALTH DAMAGE TO THE PATIENT WAS NOT CLEAR.

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

  MAUDE report 15248300 ↗
• MalfunctionSep 10, 2021Material Fragmentation; Nonstandard Device; Material Fragmentation; Nonstandard Device

  IT WAS REPORTED THAT THE TIP OF THE DRAINAGE FUNNEL IN THE FOLEY CATHETER WAS DEFORMED AND SEEMED TO BE CHIPPED AND THE DEVICE WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12455191 ↗
• MalfunctionJun 28, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE CATHETER FELL OUT AFTER THE SURGERY DUE TO WATER LEAKAGE. CATHETER WAS INSERTED AGAIN, BUT IT FELL OUT. PROBABLY, THE WATER LEAKED FROM THE LUMEN TO THE LUMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12075852 ↗
• MalfunctionMar 19, 2020Fluid/Blood Leak; Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT WATER LEAKED SOON AFTER THE PLACEMENT.

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

  MAUDE report 9853185 ↗
• MalfunctionJan 10, 2020Misassembled; Failure to Align; Misassembled

  IT WAS REPORTED THAT DURING EVALUATION THE INFLATION CAP WAS MISALIGNED.

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

  MAUDE report 9578114 ↗
• MalfunctionDec 23, 2019Misassembled; Misassembled; Blocked Connection

  IT WAS REPORTED THAT THE IRRIGATION LUMEN WAS BLOCKED.

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

  MAUDE report 9511070 ↗
• MalfunctionDec 11, 2019Misassembled; Deflation Problem; Misassembled

  IT WAS REPORTED THAT THE CATHETER BALLOON WOULD NOT DEFLATE.

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

  MAUDE report 9453215 ↗
• MalfunctionNov 25, 2019Inability to Irrigate; Inability to Irrigate; Infusion or Flow Problem

  IT WAS REPORTED THAT THE 3 WAY CATHETER WAS NOT ABLE TO BE IRRIGATED ON THE DAY OF USE. PER ADDITIONAL INFORMATION VIA EMAIL 11NOV2019, THE WATER WOULD NOT INJECT INTO THE IRRIGATION PORT AT ALL.

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

  MAUDE report 9371798 ↗
• MalfunctionJun 20, 2019Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT THE CATHETER WAS INSERTED INTO PATIENT'S ANUS. THE PATIENT ((B)(6) YEARS OLD) HAD TREATMENT FOR INTUSSUSCEPTION WITH SALINE INFUSED THROUGH DRAINAGE LUMEN OF THE CATHETER. A LOT OF SALINE LEAKED DURING THE TREATMENT, THE BALLOON WAS REMOVED AND INFLATED AGAIN. THE USER THEN FOUND THAT THE BALLOON WAS ASYMMETRICALLY INFLATED. THE USER REQUESTED US TO INVESTIGATE THE DEVICE.

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

  MAUDE report 8716838 ↗
• MalfunctionFeb 27, 2019Inability to Irrigate

  IT WAS REPORTED THAT AFTER PLACING THE CATHETER, IRRIGATION WAS ATTEMPTED, HOWEVER WATER COULD NOT BE INJECTED INTO THE IRRIGATION PORT.

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

  MAUDE report 8375583 ↗
• MalfunctionOct 3, 2018Inability to Irrigate; Blocked Connection; Inability to Irrigate

  IT WAS REPORTED THAT THE IRRIGATION LUMEN CLOGGED PRIOR TO USE.

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

  MAUDE report 7930532 ↗