Bardex® I.C. Complete Care® Foley Catheter Tray and Urine Meter 303316ARecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741024269), received between Oct 23, 2017 and Mar 25, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 25, 2026Class IIOpen, Classified

   Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

   Z-3116-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2025Inadequate or Insufficient Training; Wrong Label; Inadequate or Insufficient Training; Wrong Label

  IT WAS REPORTED THAT CUSTOMER SAID PACKAGING STATED LATEX FREE, BUT THERE WAS LATEX IN THE PACKAGE. NO ADVERSE EVENT OR PATIENT IMPACT. NURSES WERE CATCHING THIS PRIOR TO USE. PER ADDITIONAL INFORMATION RECEIVED ON 01APR2025, IT WAS REPORTED THAT CUSTOMER WHO INFORMED THAT IT WAS NOT THAT THE PACKAGING STATED LATEX FREE, BUT THERE WAS LATEX IN THE PACKAGE BUT THAT THEY WERE NOT INFORMED THAT BD WAS CHANGING FROM NO LATEX TO USING LATEX IN THE FOLEY TRAY. CUSTOMER STATED THAT HAD GOTTEN THE BIOHAZARD BOX BUT WAS NOT GOING TO SEND ANYTHING BACK, THE COMPLAINT WAS SUBMITTED BASED ON THE LACK OF NOTIFICATION THAT WAS PROVIDED TO THE FACILITY PRIOR TO THE CHANGE. CUSTOMER INFORMED THEY HAD BEEN USING THE PRODUCT FOR YEARS AND IT WAS NEVER LATEX AND PRIOR TO A PROCEDURE IT WAS NOTICED BY THE NURSE. THEY HAD OLD TRAYS THAT HAVE A BLUE DOT INDICATING ITEMS WERE NOT MADE WITH LATEX. THEY HAVE CREATED AN EDUCATION PLAN TO INFORM NURSES OF THE CHANGE AS THIS COULD BE A SAFETY CONCERN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688456 ↗
• MalfunctionOct 12, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THREE ANTISEPTIC SWAB STICKS WERE NOT IN THE FOLEY KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12615372 ↗
• MalfunctionSep 29, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT CUSTOMER NOTICED THREE OF THE ANTISEPTIC SWAB STICKS IN THE FOLEY TRAY WERE VERY STICKY AND ALSO IT DID NOT HAVE A LOT OF BETADINE ON THEM. HENCE IT WAS VERY DIFFICULT OR ALMOST IMPOSSIBLE TO PREPARE THE PATIENT¿S GENITALIA WITH THE PREPARATION STICKS AS DIRECTED BY THE MANUFACTURER¿S INSTRUCTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12547010 ↗
• MalfunctionSep 29, 2021Short Fill; Short Fill

  IT WAS REPORTED THAT THE CUSTOMER NOTICED THREE OF THE ANTISEPTIC SWAB STICKS IN THE FOLEY TRAY WERE VERY STICKY, AND ALSO IT DID NOT HAVE A LOT OF BETADINE ON THEM. HENCE, IT WAS VERY DIFFICULT OR ALMOST IMPOSSIBLE TO PREPARE THE PATIENT¿S GENITALIA WITH THE PREPARATION STICKS AS DIRECTED BY THE MANUFACTURER¿S INSTRUCTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12546178 ↗
• MalfunctionSep 16, 2020Decrease in Pressure; Device Slipped; Contamination /Decontamination Problem; Decrease in Pressure

  IT WAS REPORTED THAT THE TRAY WAS CONTAMINATED. PER ADDITIONAL INFORMATION RECEIVED FROM FOLLOW UP 2 VIA MAIL ON 28AUG2020, IT WAS REPORTED THAT THE BULB WAS INFLATED AFTER INSERTION OF FOLEY AND FOLEY FELL OUT WHICH OCCURRED ON TWO SEPARATE PATIENTS.

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

  MAUDE report 10542098 ↗
• MalfunctionOct 23, 2019Misassembled; Misassembled

  IT WAS REPORTED THAT THE FOLEY PORT WAS MANUFACTURED BACKWARDS. THE NURSE HAD TO USE A PORT TYPICALLY USED TO PULL TO DEFLATE THE BALLOON VS THE NORMAL PORT TO DEFLATE THE BALLOON. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9226932 ↗
• MalfunctionJul 17, 2019Burst Container or Vessel; Burst Container or Vessel; Deflation Problem

  IT WAS REPORTED THAT A CATHETER PREMATURELY DEFLATED AND A TEAR WAS NOTED IN THE BALLOON, APPROXIMATELY TWO HOURS AFTER INSERTION. THE CATHETER WAS INSERTED ON 6/26/19 AT 0700 IN THE OPERATING ROOM, IN A 47 YEAR OLD FEMALE UNDERGOING A TOTAL LAPAROSCOPIC HYSTERECTOMY. THE CATHETER WAS PLACED WITHOUT RESISTANCE, INFLATED WITH 10ML, AND PLACEMENT WAS CONFIRMED WITH URINE RETURN.

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

  MAUDE report 8798819 ↗
• MalfunctionOct 24, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT URINE WOULD NOT DRAIN FROM THE CATHETER.

  Patient problems: No Information

  MAUDE report 6971043 ↗
• MalfunctionOct 23, 2017No Device Output

  IT WAS REPORTED THAT URINE WOULD NOT DRAIN FROM THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6970043 ↗