Bardex® Lubricath® Foley Catheter 0167L22Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00801741018978), received between Apr 27, 2017 and Nov 21, 2025 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (6 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING USE WATER LEAKED FROM THE FOLEY CATHETER SHAFT AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619208 ↗
• MalfunctionNov 14, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING PLACEMENT BALLOON WAS RUPTURED OF THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23552879 ↗
• MalfunctionOct 24, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE PRE-TEST, THE FOLEY CATHETER BALLOON STERILE WATER COULD NOT BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23381278 ↗
• MalfunctionOct 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OF THE FOLEY CATHETER AND CAME OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347648 ↗
• MalfunctionSep 30, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING PRETESTING, WATER LEAKAGE OCCURRED WHEN WATER WAS INTRODUCED IN THE FOLEY CATHETER. SO, USE WAS DISCONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23179218 ↗
• MalfunctionJul 3, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT URINARY FOLEY CATHETER WAS BLOCKED AND WATER CANNOT BE DRAWN OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395485 ↗
• MalfunctionJun 3, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE 3-WAY CATHETER LEAKING OUT WHEN BALLOON WAS INFLATED. THEY DID NOT SAVE THE DEVICE OR TAKE A PHOTO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131805 ↗
• MalfunctionAug 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WATER LEAK OR AIR LEAK IN THE FOLEY CATHETER, REPLACE IT WITH A NEW ONE TO SOLVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20075931 ↗
• MalfunctionMay 28, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A SMALL PIN HOLE IN THE BALLOON, THE BALLOONS WERE DEFLATING AND COMING OUT OF THE PATIENT. (LOT #NGHX1678), (LOT #NGHW2924), (LOT #NGHV1207) PER CUSTOMER FOLLOW UP RECEIVED ON 20MAY2024, IT WAS REPORTED THAT THEY EXPERIENCED A DEFLATED BALLOON WHICH CAUSED FOLEY CATHETER TO COME OUT ON 3 DIFFERENT OCCASIONS. THEY NOTICED A PIN-SIZED HOLE IN THE BALLOON. LOT #NGHV1207, LOT #NGHX1678, (LOT #NGHW2934) WERE REPORTED AND TWO OF THE CATHETERS WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19407033 ↗
• MalfunctionMay 26, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON GOT BURST IN THE WARD ON THE FIFTH DAY OF DETENTION AND CATEJELLY WAS USED AS THE LUBRICANT. IT WAS STATED THAT THE EVENT HAPPENED 5 DAYS AFTER PLACEMENT AND THE BALLOON WAS RUPTURED OR TORN. THE WATER LEAKED FROM THE BALLOON. IT WAS ALSO STATED THAT NO MATERIALS WERE IN CONTACT WITH THE CATHETER OR BALLOON AND THE CATHETER WAS INSERTED BY HAND. THE PATIENT DID NOT HAVE URINE STONE AND THE CATHETER WAS PULLED RARELY. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 13MAY2022, IT WAS STATED THAT THE CATEJELLY WAS THE JELLY THAT WAS INCLUDED IN THE COMPONENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14517611 ↗
• MalfunctionMar 2, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PATIENT HEARD A LOUD POP SOUND FROM THE FOLEY CATHETER BALLOON. UPON EXAMINATION, NURSE IMMEDIATELY CHECKED THE BALLOON OF FOLEY CATHETER AND FOUND THAT IT WAS POPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653540 ↗
• MalfunctionSep 2, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS UNABLE TO DEFLATED FULLY WHEN NEEDED TO REMOVE FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12415933 ↗
• MalfunctionAug 12, 2021Misassembly by Users; Misassembly by Users

  IT WAS REPORTED THAT THE PATIENT HAD A SENTINEL EVENT FROM ITEM 0167L22. PER FOLLOW UP WITH THE CUSTOMER VIA PHONE ON 19JUL2021, IT WAS STATED THAT THERE WERE SOMETHINGS THAT CUSTOMER WAS UNABLE TO CLEARLY SAY DUE TO LEGAL BUT THAT THE PATIENT HAD A ¿POOR OUTCOME¿ AFTER THE CATHETER WAS PLACED INCORRECTLY BY A NURSE. ALSO STATED THAT THEY COULD NOT SPECIFICALLY BLAME THE OUTCOME ONLY ON THE CATHETER PLACEMENT. THEY WOULD LIKE FOR THE INSTRUCTIONS TO BE WRITTEN CLEARER BECAUSE IT APPEARS THAT CATHETER WAS PLACED BACKWARDS ON THE PATIENT CAUSING URINE TO GO THROUGH THE IRRIGATION PORT. SHE DID SPECIFY THAT THE PATIENT HAD BLOOD CLOTS.

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

  MAUDE report 12313689 ↗
• MalfunctionJul 14, 2021Illegible Information; Missing Information; Illegible Information; Missing Information

  IT WAS REPORTED THAT THE IRRIGATION PORT AND THE DRAINAGE PORT ON THE BARD RIBBED BALLOON 3-WAY CONTINUOUS IRRIGATION FOLEY MIGHT NOT BE ADEQUATELY LABELLED. THERE WERE THREE PORTS ON THE DISTAL END OF THE FOLEY CATHETER. ONE PORT WAS CLEARLY IDENTIFIABLE AND WAS FOR THE INFLATION AND DEFLATION OF THE BALLOON THAT HOLDS THE CATHETER IN PLACE IN THE BLADDER. THE OTHER TWO PORTS, ONE IN THE MIDDLE FOR DRAINAGE AND ONE ON THE OUTSIDE OPPOSITE THE BALLOON INFLATION PORT FOR IRRIGATION WERE NOT CLEARLY IDENTIFIED ON THE CATHETER ITSELF. THE POTENTIAL EXISTED FOR A HEALTHCARE PROVIDER TO MIX UP THE PORTS AND CONNECT THE IRRIGATION BAG TO THE DRAINAGE PORT AND THE DRAINAGE BAG TO THE IRRIGATION PORT. THIS COULD POTENTIALLY CAUSE PATIENT HARM AS THE BLADDER WOULD NOT BE ADEQUATELY IRRIGATED AND DRAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12170337 ↗
• MalfunctionSep 4, 2020Break; Deflation Problem; Material Fragmentation; No Flow; Material Fragmentation

  IT WAS REPORTED THAT BULBS ARE NOT DEFLATING, CATHETERS ARE SNAPPING, AND CATHETERS OFTEN BECOME AIR LOCKED AND WON'T DRAIN.

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

  MAUDE report 10493608 ↗
• MalfunctionSep 4, 2020Break; Deflation Problem; Difficult to Remove; No Flow; Difficult to Remove

  IT WAS REPORTED THAT BULBS ARE NOT DEFLATING, CATHETERS ARE SNAPPING, AND CATHETERS OFTEN BECOME AIR LOCKED AND WON'T DRAIN.

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

  MAUDE report 10493607 ↗
• MalfunctionSep 2, 2020Deflation Problem; Inaccurate Flow Rate; No Flow; Inaccurate Flow Rate

  IT WAS REPORTED THAT BULBS ARE NOT DEFLATING, CATHETERS ARE SNAPPING, AND CATHETERS OFTEN BECOME AIR LOCKED AND WON'T DRAIN.

  Patient problems: Insufficient Information; No Consequences Or Impact To Patient

  MAUDE report 10485461 ↗
• MalfunctionApr 3, 2020Fluid/Blood Leak; Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE CATHETER FELL OUT OF THE PATIENT DUE TO A WATER LEAK IN THE BALLOON. THE EVENT OCCURRED ON THE DAY AFTER PLACEMENT.

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

  MAUDE report 9923272 ↗
• MalfunctionSep 11, 2019Deflation Problem; Device Fell; Deflation Problem

  IT WAS REPORTED THAT THE CATHETER FELL OUT WITH A DEFLATED BALLOON.

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

  MAUDE report 8996872 ↗
• MalfunctionMay 14, 2019Partial Blockage; Obstruction of Flow; Partial Blockage

  IT WAS REPORTED THAT THE IRRIGATION LUMEN ON THE CATHETER WAS BLOCKED WHICH CAUSED A RESTRICTION TO THE FLOW. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 8608498 ↗
• MalfunctionFeb 6, 2019Deflation Problem; Inflation Problem; Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE CATHETER BALLOON WAS DIFFICULT TO INFLATE AND DIFFICULT TO DEFLATE. IT WAS LATER REPORTED BY THE INTERNATIONAL BUSINESS CENTER (IBC) VIA EMAIL (B)(6) 2019 THAT THE CATHETER WAS USED ON A PATIENT AND IT WAS DIFFICULT TO DEFLATE THE BALLOON.

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

  MAUDE report 8311040 ↗
• MalfunctionJun 18, 2018Partial Blockage

  IT WAS REPORTED THAT THE IRRIGATION LUMEN OF THE CATHETER WAS BLOCKED AND NOT ABLE TO BE USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7612002 ↗
• MalfunctionMay 2, 2017Inflation Problem; Device Slipped

  IT WAS REPORTED THAT THE BALLOON INFLATION PORT WAS PUNCTURED. THE BALLOON, SUBSEQUENTLY DID NOT REMAIN INFLATED POST-INSERTION. THE FOLEY ALLEGEDLY SLIPPED OUT OF PATIENT REQUIRING RE-CATHETERIZATION A FEW HOURS POST-OP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6536645 ↗
• MalfunctionApr 27, 2017Inability to Irrigate

  IT WAS REPORTED THAT THE CATHETER COULD NOT BE IRRIGATED. THE CATHETER WAS REPLACED WITHOUT FURTHER INCIDENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6526218 ↗