Bardex® Lubricath® Hematuria Foley Catheter 2551H22Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00801741025150), received between Jun 27, 2020 and Mar 30, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Inability to Irrigate” (5 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.

• MalfunctionMar 30, 2026Material Puncture/Hole

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714046 ↗
• MalfunctionMar 16, 2026Inflation Problem; Inability to Irrigate

  IT WAS REPORTED THAT DURING PLACEMENT WHEN ATTEMPTING TO FILL THE FOLEY CATHETER BALLOON WITH STERILE WATER, THE WATER DID NOT ENTER. THE TROUBLESHOOTING PROCEDURE IN THE NOTICE DOCUMENT WAS NOT TRIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24613015 ↗
• MalfunctionFeb 20, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING PLACEMENT, DUE TO LOW URINE OUTPUT EVEN AFTER PLACEMENT, THE CATHETER WAS DISCONNECTED FROM THE DRAIN BAG THE CATHETER EXPERIENCED FOREIGN OBJECT CONTAMINATION WHEN, UPON DISCONNECTING THE CATHETER FROM THE DRAIN BAG AND ATTEMPTING TO ASPIRATE WITH THE CATHETER TIP, A FOREIGN OBJECT WAS FOUND CLOGGING THE INTERIOR OF THE DRAINAGE FUNNEL, AND THE LOT NUMBER WAS UNKNOWN/UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406867 ↗
• MalfunctionFeb 12, 2026Difficult to Remove

  IT WAS REPORTED THAT AFTER PLACEMENT THE FOLEY CATHETER HAD DIFFICULTY IN WATER WITHDRAWAL. THE SYRINGE WAS MADE BY ANOTHER COMPANY AND WOULD BE INCLUDED IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24326345 ↗
• MalfunctionJan 17, 2026Difficult to Remove

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER HAD DIFFICULTY IN WATER INJECTION AND WATER WITHDRAWAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24105489 ↗
• MalfunctionJan 17, 2026Inflation Problem

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER HAD DIFFICULTY IN WATER INJECTION AND WATER WITHDRAWAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24105488 ↗
• MalfunctionOct 7, 2025Inflation Problem; Inability to Irrigate; Inflation Problem; Inability to Irrigate

  IT WAS REPORTED THAT DURING PRE-TEST THE FOLEY CATHETER STERILE WATER DID NOT ENTER THROUGH THE INFLATION VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23235164 ↗
• MalfunctionSep 19, 2025Inflation Problem; Inability to Irrigate; Inflation Problem; Inability to Irrigate

  IT WAS REPORTED THAT AFTER PLACEMENT, THE USER CONNECTED THE LINE AND ADMINISTERED SALINE BUT WAS UNABLE TO PERFUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095836 ↗
• MalfunctionJul 21, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS BURST OF THE FOLEY CATHETER BALLOON AND WHEN CUT THE BALLOON AND LOOKED INSIDE, THERE WERE QUITE A FEW FOREIGN OBJECTS STUFFED IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554951 ↗
• MalfunctionJul 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THERE WAS BURST OF THE FOLEY CATHETER BALLOON AND WHEN CUT THE BALLOON AND LOOKED INSIDE, THERE WERE QUITE A FEW FOREIGN OBJECTS STUFFED IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543053 ↗
• MalfunctionJul 3, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT PATIENT WAS USING 3-WAY HEMATURIA (2550H22) BECAUSE THE 2-WAY (2551H22) WAS DISCONTINUED. HOWEVER, THE THIRD LUMEN WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395528 ↗
• MalfunctionJul 3, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT PATIENT WAS USING 3-WAY HEMATURIA (2550H22) BECAUSE THE 2-WAY (2551H22) WAS DISCONTINUED. HOWEVER, THE THIRD LUMEN WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395519 ↗
• MalfunctionJul 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS CONSTANTLY LEAKING IN PAST 2 DAYS. CUSTOMER REQUESTED REPLACEMENT AND POSSIBLY CHANGE TO DIFFERENT CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386702 ↗
• MalfunctionMay 13, 2025Material Puncture/Hole; Device Dislodged or Dislocated; Material Puncture/Hole; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS PLACED IN THE OPERATING ROOM WITH 50ML OF FIXED WATER. APPROXIMATELY 9 HOURS LATER AFTER RETURNING TO THE ROOM THE CATHETER WAS NATURALLY REMOVED. THE BALLOON HAD DEFLATED. THE DOCTOR INFLATED THE BALLOON OF THE REMOVED CATHETER, BUT NO LEAKS OR TEARS WERE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009538 ↗
• MalfunctionMay 6, 2025Fracture; Material Rupture; Fracture; Material Rupture

  IT WAS REPORTED THAT WHEN THE DOCTOR INSERTED STERILE DISTILLED WATER AFTER PLACEMENT OF THE FOLEY CATHETER, A POPPING SOUND WAS HEARD. AFTER THAT, THE CATHETER CAME OUT AND BALLOON WAS RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968494 ↗
• MalfunctionApr 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS A CRACK IN THE FOLEY CATHETER, AND IT WAS SAID THAT STERILE WATER LEAKED DURING THE PRE-TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21805911 ↗
• MalfunctionFeb 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE IMMEDIATELY AFTER PLACEMENT, THE FOLEY CATHETER BALLOON HAD RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21304212 ↗
• MalfunctionDec 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS USED FOR CONTINUOUS BLADDER IRRIGATION IN PATIENTS WITH HEMATURIA AND CLOUDY URINE. AFTER 1 TO 1.5 MONTHS OF USE AND NOTICED THAT THERE WERE CRACKS IN THE 3WAY PART OF THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20939039 ↗
• MalfunctionOct 28, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER UROPATHY, 2551HT22 WAS INSERTED. CONTINUOUS BLADDER IRRIGATION WAS STARTED, AND A HOLE WAS FOUND AT THE BASE OF THE 3WAY FOLEY CATHETER, CAUSING REFLUX WATER LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20546072 ↗
• MalfunctionJul 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE DAY AFTER IMPLANTATION, A POPPING SOUND WAS HEARD AND UPON CHECKING, THE FOLEY CATHETER HAD FELL OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19792571 ↗
• MalfunctionSep 14, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOON WAS FOUND TO BE LEAKING WHILE CHECKING THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417842 ↗
• MalfunctionSep 2, 2022Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn

  IT WAS REPORTED THAT A HOLE WAS FOUND AT END OF IRRIGATION OUTLET OF THE FOLEY CATHETER. ANOTHER FOLEY CATHETER WAS INSERTED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15347357 ↗
• MalfunctionMar 31, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT CATHETER BLOCKAGE, LEAKAGE, PAIN AND RETAINED FRAGMENTS FROM CATHETER WHEN THEY WERE ASKED OF COMPLICATIONS WHILE USING THE FOLEY CATHETER. MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13971421 ↗
• MalfunctionMar 31, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED LEAKAGE WHEN THEY WERE ASKED ABOUT THE COMPLICATIONS WHILE USING THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13959708 ↗
• MalfunctionJan 26, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE WATER DID NOT COME OUT FROM THE BALLOON OF THE FOLEY CATHETER. PER FOLLOW UP VIA IBC ON 19JAN2021, IT WAS UNKNOWN HOW THE WATER REMOVED FROM THE BALLOON OF THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11232488 ↗