Bardex® Lubricath® Hematuria Foley Catheter 2550H22Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741025099), received between Dec 28, 2020 and Jul 13, 2022 — classified as 2 injuries, 2 malfunctions.

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

• InjuryJul 13, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT AN URINARY FOLEY CATHETER WAS PLACED AT THE TIME OF SURGERY UNDER GENERAL ANESTHESIA. THE PATIENT STATED THAT THE CATHETER FELL OFF WHEN THE PATIENT WENT TO THE BATHROOM. UPON CHECKING THE CATHETER, THE BALLOON WAS FOUND TO BE RUPTURED AND A NEW CATHETER WAS INSERTED AGAIN. IT WAS STATED THAT A SECOND BALLOON WAS ALSO RUPTURED. THE INSIDE OF THE BLADDER WAS OBSERVED BY ECHO AND IT WAS CONFIRMED THAT THERE WAS NO FOREIGN MATTER IN IT. PER FOLLOW UP VIA IBC ON 28JUN2022, TWO SAMPLES WERE RECEIVED (MANUFACTURING LOT# 9HZ059, MANUFACTURING LOT# 1KS057).

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

  MAUDE report 15007703 ↗
• InjuryJul 12, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT AN URINARY FOLEY CATHETER WAS PLACED AT THE TIME OF SURGERY UNDER GENERAL ANESTHESIA. THE PATIENT STATED THAT THE CATHETER FELL OFF WHEN THE PATIENT WENT TO THE BATHROOM. UPON CHECKING THE CATHETER, THE BALLOON WAS FOUND TO BE RUPTURED AND A NEW CATHETER WAS INSERTED AGAIN. IT WAS STATED THAT A SECOND BALLOON WAS ALSO RUPTURED. THE INSIDE OF THE BLADDER WAS OBSERVED BY ECHO AND IT WAS CONFIRMED THAT THERE WAS NO FOREIGN MATTER IN IT.

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

  MAUDE report 14985808 ↗
• MalfunctionMar 2, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE FOLEY CATHETER FELL OUT OF A PATIENT DUE TO A BALLOON RUPTURE SOON AFTER PLACEMENT. IT WAS ALSO STATED THAT THE EVENT OCCURRED DURING A UROLOGY SURGERY. PER FOLLOW UP VIA IBC ON 12FEB2021, THE BALLOON RUPTURED WAS NOT OBSERVED TO THE RETURNED SAMPLE AND THERE WAS NO MISSING PIECES FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11399844 ↗
• MalfunctionDec 28, 2020Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE FOLEY CATHETER FELL OUT A FEW HOURS AFTER THE PLACEMENT.

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

  MAUDE report 11077393 ↗