Bardex® Lubricath® Foley Catheter 0166L24Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741017629), received between Oct 8, 2019 and Jan 26, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Inflation Problem

  IT WAS REPORTED THAT THE PATIENT SAID THE FOLEY WAS DEFECTIVE, WOULD NOT INFLATE. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24185758 ↗
• MalfunctionNov 21, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER CAME OUT AND HAD TO DRIVE TO WITH SHIRT OVER IT HAD PAIN FROM PUTTING IT BACK IN. NO MEDICAL INTERVENTION WAS REPORTED. PER ADDITIONAL CLARIFICATION RECEIVED ON 07NOV2024, IT WAS REPORTED THAT THE PATIENT WAS DRIVING THE WATER OUT OF THE BALLOON ON THE FOLEY, AND THE CATHETER CAME OUT. THE CUSTOMER SAID THAT THEY HAD TO PUT THE JACKET ON THE AREA AND TRY TO REINSERT THE FOLEY. THE CUSTOMER SAID AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, THE PATIENT WAS EVENTUALLY ABLE TO GET THE CATHETER REINSERTED. THE CUSTOMER ADDED THAT THE NEXT DAY THEY HAD SOME PAIN, SAID IT FELT LIKE THEY HAD BEEN PUNCHED IN THE STOMACH. THE CUSTOMER SAID THEY WOULD TALK WITH THE DOCTOR ABOUT IT.

  Patient problems: Pain

  MAUDE report 20745747 ↗
• MalfunctionOct 30, 2019Break; Deflation Problem

  IT WAS REPORTED THAT A FOLEY CATHETER DEFLATED PREMATURELY. A 24 FRENCH FOLEY CATHETER WAS FOUND ON THE PATIENTS BED DEFLATED AND WITH A BROKEN BALLOON. ALL THE PIECES OF THE BALLOON WERE PRESENT.

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

  MAUDE report 9255047 ↗
• MalfunctionOct 8, 2019Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER'S BALLOON BURST WITHIN 24 HOURS OF USE. THE COMPLAINANT REPORTEDLY INFLATED THE BALLOON WITH 15-20CC OF TAP WATER. THERE WAS NO IMPACT TO THE PATIENT AND NO PIECES OF THE BALLOON WERE OBSERVED TO BE MISSING.

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

  MAUDE report 9167799 ↗
• MalfunctionOct 8, 2019Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER'S BALLOON BURST WITHIN 24 HOURS OF USE. THE COMPLAINANT REPORTEDLY INFLATED THE BALLOON WITH 15-20CC OF TAP WATER. THERE WAS NO IMPACT TO THE PATIENT AND NO PIECES OF THE BALLOON WERE OBSERVED TO BE MISSING.

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

  MAUDE report 9167786 ↗
• MalfunctionOct 8, 2019Burst Container or Vessel; Material Rupture; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER'S BALLOON BURST WITHIN 24 HOURS OF USE. THE COMPLAINANT REPORTEDLY INFLATED THE BALLOON WITH 15-20CC OF TAP WATER. THERE WAS NO IMPACT TO THE PATIENT AND NO PIECES OF THE BALLOON WERE OBSERVED TO BE MISSING.

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

  MAUDE report 9167780 ↗
• MalfunctionOct 8, 2019Break; Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER'S BALLOON BURST WITHIN 24 HOURS OF USE. THE COMPLAINANT REPORTEDLY INFLATED THE BALLOON WITH 15-20CC OF TAP WATER. THERE WAS NO IMPACT TO THE PATIENT AND NO PIECES OF THE BALLOON WERE OBSERVED TO BE MISSING.

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

  MAUDE report 9167775 ↗
• MalfunctionOct 8, 2019Burst Container or Vessel; Material Rupture; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER'S BALLOON BURST WITHIN 24 HOURS OF USE. THE COMPLAINANT REPORTEDLY INFLATED THE BALLOON WITH 15-20CC OF TAP WATER. THERE WAS NO IMPACT TO THE PATIENT AND NO PIECES OF THE BALLOON WERE OBSERVED TO BE MISSING.

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

  MAUDE report 9166527 ↗