Bardex® Lubricath® Foley Catheter 0166L14Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741017575), received between Aug 30, 2024 and Oct 15, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT ADVISED THAT PRODUCT STATES THAT THIS WAS 35 ML BALLOON ON THE FOLEY CATHETER PRODUCT, THIS WAS NOTICED BY THE PATIENT'S NURSE AS WELL AS THE PATIENT. THEY WERE ASKED TO CHECK FOR THE PRODUCT CODE, AND THE CODE WAS CORRECT SO IT'S THE RIGHT ITEM, BUT THE DESCRIPTION SAID IT SHOULD BE A 30ML BALLOON. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23295504 ↗
• InjuryAug 6, 2025Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE PATIENT HAD INDWELLING FOLEY CATHETER. CATHETER ORDERED TO BE REMOVED. BALLOON DEFLATED ENTIRELY BUT UNABLE TO REMOVE SAME, RESISTANCE AT THE END OF THE CATHETER AND VERY PAINFUL FOR PATIENT. LIDOCAINE APPLIED AND CATHETER NEEDED TO BE REMOVED BY MD. AFTER REMOVAL, CATHETER EXAMINED, APPEARED TO HAVE ROLLED OVER ON ITSELF, CREATING A WIDENED LIP AT THE END, MAKING REMOVAL DIFFICULT AND VERY PAINFUL FOR PATIENT.

  Patient problems: Pain

  MAUDE report 22727554 ↗
• MalfunctionJul 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE CLIENT HEARD AND FELT A POP IN THEIR ABDOMEN, WHICH WAS PAINFUL. CLIENT CAME TO CLINIC FOR ASSESSMENT URINARY CATHETER HAD MIGRATED PARTIALLY OUT OF PENIS, ON REMOVAL OF CATHETER THERE WAS NO NORMAL SALINE IN DEFLATE AND WHEN CATHETER REMOVED THE BALLOON WAS NOT INTACT HAD TEAR IN IT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 22588084 ↗
• MalfunctionJun 23, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT WHEN A PRE-TEST WAS CONDUCTED TO PLACE A FOLEY CATHETER IN THE OUTPATIENT CLINIC, THE STERILE WATER DID NOT DRAIN OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309665 ↗
• MalfunctionJun 23, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT WHEN A PRE-TEST WAS CONDUCTED TO INSERT A FOLEY CATHETER IN THE OUTPATIENT CLINIC, STERILE WATER DID NOT COME OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309664 ↗
• MalfunctionAug 30, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHILE PREPARING A NEW CATHETER FOR INSERTION AND WHILE APPLYING LUBRICANT, IT WAS NOTED THAT THE TIP OF THE CATHETER WAS DAMAGED WITH A SMALL TEAR PRESENT ON ONE SIDE. THE CATHETER WAS FROM A NEW BOX AND REMOVED FROM SEALED STERILE PACKAGING WITH NO VISIBLE BREAKS OR TEARS IN PACKING LAYERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20107746 ↗