Bardex® Lubricath® Foley Catheter 01237524Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741017742), received between Dec 5, 2019 and Apr 7, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2021Burst Container or Vessel; Decrease in Pressure; Burst Container or Vessel; Decrease in Pressure

  IT WAS REPORTED THAT THE CUSTOMER HAD TWO ISSUES THIS WEEK WITH DEFECTIVE FOLEY CATHETERS. THE FIRST ONE HAD A SMALL LEAK. THE SECOND ONE HAD A BALLOON THAT BROKE. PER FOLLOW UP MADE ON 12MAR2021, INITIALLY IT WAS REPORTED THAT THE BALLOON BURST ON THE SECOND PATIENT BUT INSTEAD WHEN TESTED AND NOTED, THE BALLOON WAS INTACT AND THE LEAK WAS INSIDE THE BALLOON AND NO PIECES WERE MISSING. THE SECOND ONE WAS INFLATED WITH 80ML OF SALINE WATER. PER ADDITIONAL INFORMATION VIA EMAIL ON 17MAR2021, CUSTOMER MENTIONED THAT THEY HAD ONE MORE BALLOON BURST. PER ADDITIONAL FOLLOW UP INFORMATION RECEIVED ON 20MAR2021, THERE WAS NO MISSING PIECES FROM THIS BALLOON AND 80CC FLUID WAS INFLATED WITH SALINE. NO MEDICAL INTERVENTION WAS REPORTED OTHER THAN PATIENT INCONVENIENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627579 ↗
• MalfunctionMar 30, 2021Fluid/Blood Leak; Decrease in Pressure; Fluid/Blood Leak; Decrease in Pressure

  IT WAS REPORTED THAT THE CUSTOMER HAD TWO ISSUES THIS WEEK WITH DEFECTIVE FOLEY CATHETERS. THE FIRST ONE HAD A SMALL LEAK. THE SECOND ONE HAD A BALLOON THAT BROKE. PER FOLLOW UP MADE ON 12MAR2021, INITIALLY IT WAS REPORTED THAT THE BALLOON BURST ON THE SECOND PATIENT, BUT WHEN TESTED IT WAS NOTED THAT THE BALLOON WAS INTACT AND THE LEAK WAS INSIDE THE BALLOON AND NO PIECES WERE MISSING. THE SECOND ONE WAS INFLATED TO 80 ML WITH SALINE WATER. PER ADDITIONAL INFORMATION VIA EMAIL ON 17MAR2021, CUSTOMER MENTIONED THAT THEY HAD ONE MORE BALLOON BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11592577 ↗
• MalfunctionMar 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER HAD TWO ISSUES THIS WEEK WITH DEFECTIVE FOLEY CATHETERS. THE FIRST ONE HAD A SMALL LEAK. THE SECOND ONE HAD A BALLOON THAT BROKE. PER FOLLOW UP MADE ON 12MAR2021, INITIALLY IT WAS REPORTED THAT THE BALLOON BURST ON THE SECOND PATIENT, BUT WHEN TESTED IT WAS NOTED THAT THE BALLOON WAS INTACT AND THE LEAK WAS INSIDE THE BALLOON AND NO PIECES WERE MISSING. THE SECOND ONE WAS INFLATED TO 80ML WITH SALINE WATER. PER ADDITIONAL INFORMATION VIA EMAIL ON 17MAR2021, CUSTOMER MENTIONED THAT THEY HAD ONE MORE BALLOON BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11592439 ↗
• MalfunctionApr 30, 2020Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED UPON EVALUATION THAT THE BALLOON ON THE FOLEY CATHETER WOULD NOT COMPLETELY DEFLATE.

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

  MAUDE report 10014938 ↗
• MalfunctionApr 30, 2020Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE REMAINING WATER DID NOT DEFLATE OUT OF THE BALLOON.

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

  MAUDE report 10014862 ↗
• MalfunctionApr 30, 2020Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT A LUMEN TO LUMEN LEAK WAS FOUND DURING THE SAMPLE EVALUATION.

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

  MAUDE report 10014834 ↗
• MalfunctionMar 4, 2020Burst Container or Vessel; Material Rupture; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON "RUPTURED".

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

  MAUDE report 9788036 ↗
• MalfunctionMar 4, 2020Burst Container or Vessel; Material Rupture; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON "RUPTURED".

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

  MAUDE report 9787967 ↗
• MalfunctionDec 5, 2019Deflation Problem; Deflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT TWO FOLEY BALLOONS DEFLATED PREMATURELY DURING USE. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 9416524 ↗
• MalfunctionDec 5, 2019Deflation Problem

  IT WAS REPORTED THAT TWO FOLEY BALLOONS DEFLATED PREMATURELY DURING USE. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 9416048 ↗