Bardex® Lubricath® Foley Catheter 0165L20Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00801741017506), received between Jul 7, 2017 and Aug 20, 2026 — classified as 6 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (13 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 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50351328 ↗
• InjuryAug 14, 2026Complete Blockage

  It was reported that the Latex Foley Catheter few hours after that were inserted, it stopped flowing. The customer sought medical attention at the hospital and was advised that the catheter was obstructed due to a blockage within the balloon. Customer sought medical attention.

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

  MAUDE report 50256573 ↗
• MalfunctionAug 6, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50160197 ↗
• MalfunctionJul 27, 2026Material Puncture/Hole

  It was reported by the customer that the Foley catheter balloon leaked. The catheter was placed; however, it came out after 5 minutes. Upon inspection, the balloon was inflated and found to be leaking, resulting in deflation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50022033 ↗
• MalfunctionApr 25, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A WATER LEAK IN THE VICINITY OF THE CONNECTION OF THE FOLEY CATHETER, AS THERE WERE CRACKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24991590 ↗
• MalfunctionApr 11, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PT SAID THAT THE BALLOON LEAKED. 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 24848898 ↗
• MalfunctionMar 31, 2026Dent in Material

  IT WAS REPORTED THAT ON 26MAR2026, CONTACT WAS MADE FROM THE MEDICAL INSTITUTION TO THE AGENCY REPRESENTATIVE. A RETURN REQUEST WAS MADE DUE TO A DEFECT IN THE FOLEY CATHETER BALLOON'S PARTIAL INFLATION. THE PRODUCT IN QUESTION HAS ALREADY BEEN RETURNED BY THE MEDICAL INSTITUTION.

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

  MAUDE report 24749085 ↗
• MalfunctionMar 23, 2026Inflation Problem

  IT WAS REPORTED THAT DURING USE, WHEN INFLATING THE FOLEY CATHETER BALLOON, THE TUBE NORMALLY ENDS UP IN THE CENTER, BUT IT WAS REPORTED THAT TWO BALLOONS IN A ROW INFLATED WITH THE TUBE SHIFTED TO THE EDGE. PER FOLLOW UP INFORMATION RECEIVED VIA RCC ON 19-MAR-2026 STATED THAT THE EVENT OCCURRED DURING PRETEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670385 ↗
• InjuryFeb 27, 2026Difficult to Remove

  IT WAS REPORTED THAT PATIENT HAD PROBLEMS REMOVING THE FOLEY CATHETER THEY SAID WAS UNABLE TO REMOVE THE WATER FROM THE BALLOON AND HAD TO GO TO THE HOSPITAL.

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

  MAUDE report 24475110 ↗
• MalfunctionDec 10, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT STATED THE STERILE WATER WOULD NOT GO INTO THE FAULTY CATHETER INSTEAD IT WAS GOING INTO THE BALLOON. THE WATER WOULD NOT GO INTO THE CATHETER WHICH CAUSED THE BALLOON TO INFLATE BEFORE IT COULD BE INSERTED. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED. PER CLARIFICATION RECEIVED ON 20DEC2025, IT WAS REPORTED THAT THE WIFE INSERTED THE CATHETER FOR HER HUSBAND, BUT SHE WAS NOT ABLE TO FILL THE BALLOON. SHE SAID WHEN SHE INSERTED THE SYRINGE AND TRIED TO PUSH THE PLUNGER "IT JUST BLEW UP" SOUNDS LIKE THE WATER WAS JUST NOT FLOWING TO THE BALLOON. SO, SHE REMOVED THE CATHETER AND TRIED TO INFLATE THE BALLOON, AND IT WORKED FINE. SO, SHE DRAINED THE BALLOON, REINSERTED THE CATHETER, AND THE BALLOON FILLED AS IT SHOULD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771541 ↗
• MalfunctionDec 9, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD OBSTRUCTION DUE TO URINE BLOCKAGE IN THE FOLEY CATHETER WITHIN ONE WEEK AFTER INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23764805 ↗
• MalfunctionNov 12, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT IMMEDIATELY AFTER STARTED USING THE FOLEY CATHETER HAD LEAKAGE OF STERILE WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533581 ↗
• MalfunctionNov 5, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT WHO HAD A FOLEY CATHETER INSERTED ON (B)(6) 2025 HAD THE CATHETER REMOVED SPONTANEOUSLY ON THE (B)(6) 2025. IT WAS ALSO MENTIONED THAT CUSTOMER ASKED US TO CHECK IF THERE WERE ANY PROBLEMS WITH THE ACTUAL PRODUCT AND ALSO SAID THAT THERE WERE NO EXTERNAL FACTORS SUCH AS THE PATIENT HAVING A LOT OF STONES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479483 ↗
• MalfunctionOct 17, 2025Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT DURING THE PRE-TEST THERE WAS A REPORT THAT THE FOLEY CATHETER BALLOON COULD NOT BE EXPANDED, IT HAD DIFFICULTY IN INJECTING WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23321700 ↗
• MalfunctionOct 15, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON DID NOT INFLATE DURING TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291262 ↗
• MalfunctionSep 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT SPONTANEOUS REMOVAL OF FOLEY CATHETER WAS DISCOVERED ON THE SECOND DAY AFTER PLACEMENT. OBSERVATION OF THE CUFF REVEALED DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23111146 ↗
• MalfunctionJul 28, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT ONE OF THE FOLEY CATHETER ITEMS HAD A STICKER INDICATING 5ML INSTEAD OF 10ML, THE ONE AT THE TOP. ADDITIONALLY, THE PACKAGING DIFFERS AS THE TOP PRODUCT APPEARED TO BE FROM BD, WHILE THE OTHER WAS FROM BARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631171 ↗
• MalfunctionJun 25, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT IMMEDIATELY AFTER INSERTING THE FOLEY CATHETER INTO THE PATIENT, WHEN THEY TRIED TO INFLATE THE BALLOON, WATER LEAKED FROM A PART SLIGHTLY BELOW WHERE THE WATER WAS POURED. IT WAS NOT LEAKING INSIDE THE BODY. LEAK LOCATION NEAR THE VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329772 ↗
• MalfunctionMay 23, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE REGULAR LEAKS FROM THE BAG OR FOLEY CATHETER BALLOON. INSTEAD OF CATHETERIZING THE PATIENT EVERY 4 TO 6 WEEKS, NURSES MUST CATHETERIZE THEM EVERY WEEK. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 09MAY2025, STATED THAT THEY SAW THE NURSE ON WEDNESDAY AND THEY TOLD THEM ABOUT IT AGAIN. ACCORDING TO THE CUSTOMER, ONCE THE LEAK TAKES PLACE IN THE BALLOON, ONCE ON THE COLLECTOR, SOMETIMES THE TUBING COMES OFF THE BAG. IT WAS HARD TO KNOW WHERE THE PROBLEM WAS, BUT THE PRODUCT SATISFACTION IS NOT THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078276 ↗
• InjuryMay 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT EXPERIENCED FOLEY DISLODGEMENT WHEN THEY GOT HOME FROM THE FACILITY. BALLOON FAILURE ON TWO OF THE FOLEYS (PCN#0165L16 AND PCN#0165L20).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968335 ↗
• MalfunctionApr 29, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT'S WIFE SAID THE FOLEY CATHETER KEPT BENDING AND TWISTING, THEY HAD TO CHANGE WITHIN TWO DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926600 ↗
• MalfunctionFeb 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 1ST DAY AFTER PLACEMENT, NO PROBLEM DURING PRE-TEST. THE FOLEY CATHETER WAS NATURALLY REMOVED. WHEN OBSERVING THE CATHETER, THE BALLOON WAS BROKEN. THIS INCIDENT OCCURRED IN THE SAME PATIENT, BUT THE DATES OF OCCURRENCE WERE DIFFERENT (DOE (B)(6) 2025), (DOE (B)(6) 2025), (DOE (B)(6) 2025).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21462166 ↗
• MalfunctionFeb 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 1ST DAY AFTER PLACEMENT, NO PROBLEM DURING PRE-TEST. THE FOLEY CATHETER WAS NATURALLY REMOVED. WHEN OBSERVING THE CATHETER, THE BALLOON WAS BROKEN. THIS INCIDENT OCCURRED IN THE SAME PATIENT, BUT THE DATES OF OCCURRENCE WERE DIFFERENT (DOE -(B)(6) 2025), (DOE- (B)(6) 2025), (DOE -(B)(6) 2025).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21460741 ↗
• InjuryFeb 14, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS NOT DEFLATING. PER FOLLOW UP VIA EMAIL ON 07FEB2025. IT WAS REPORTED THAT THE PRODUCT CATALOG NUMBER WAS 0165L20 AND THE LOT NUMBER WAS NGJU2545. THE PATIENT WAS IDENTIFIED AS A FEMALE. THE CATHETER BROKE INSIDE THE PATIENT, BUT THE CATHETER CAME OUT OF THE PATIENT. THERE WAS NO HARM, BUT CATHETER WAS REPLACED. THE PATIENT CAME INTO THE CLINIC AND STATED THAT THE CATHETER HAD COME OUT DUE TO THE BALLOON POPPING. THE CUSTOMER WAS AT HOME WHEN IT HAPPENED AND THEN WENT TO THE EMERGENCY DEPARTMENT TO HAD IT REPLACED. THE PATIENT STATED THIS WAS THE SECOND TIME IT HAD HAPPENED AND WOULD NOT ALLOW STAFF TO USE THE SAME KIND OF CATHETER AGAIN. THE PATIENT BROUGHT THE CATHETER INTO THE CLINIC. CURRENTLY STAFF HAD IT IN MATERIALS READY TO GO OUT TO THE MANUFACTURER.

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

  MAUDE report 21385194 ↗
• MalfunctionJan 16, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS RECALLED, FOR STERILE WATER LEAKED FROM THE BALLOON DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21168340 ↗