Bardex I.C. Complete Care Foley Catheter Tray and Urine MeterRecalls & reported problems across all models

We found 3 models of Bardex I.C. Complete Care Foley Catheter Tray and Urine Meter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 11 adverse event reports in the FDA's MAUDE database, received between Oct 23, 2017 and Mar 25, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (2 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Bardex I.C. Complete Care Foley Catheter Tray and Urine Meter recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 3 of these models · Recall details · FDA record ↗

Most reported Bardex I.C. Complete Care Foley Catheter Tray and Urine Meter problems

Bardex I.C. Complete Care Foley Catheter Tray and Urine Meter models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Bardex® I.C. Complete Care® Foley Catheter Tray and Urine Meter 303316A

  CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
  1 recall9 reports
• Bardex® I.C. Complete Care® Foley Catheter Tray and Urine Meter 303318A

  CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
  1 recall2 reports
• Bardex® I.C. Complete Care® Foley Catheter Tray and Urine Meter 303314A

  CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
  1 recall0 reports

Recent Bardex I.C. Complete Care Foley Catheter Tray and Urine Meter adverse event reports

The 11 most recent reports across all models, 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 ↗
• InjuryApr 25, 2019Deflation Problem

  IT WAS REPORTED THAT THE CATHETER WOULD NOT DEFLATE. THE PATIENT WAS TAKEN TO THE CLINIC FOR URETHROSCOPY TO DEFLATE THE FOLEY BALLOON WITH A BOTOX NEEDLE AND IT WAS REMOVED WITHOUT DIFFICULTY.

  Patient problems: No Known Impact Or Consequence To Patient; Patient Problem/Medical Problem

  MAUDE report 8550284 ↗
• MalfunctionJun 12, 2018Restricted Flow rate; No Flow; Restricted Flow rate

  IT WAS REPORTED THAT THERE HAVE BEEN INSTANCES WHERE THE PATIENTS HAVE NOT HAD GOOD URINE OUTPUT. WHEN THE FOLEY WAS FLUSHED, REPLACED, OR THE BLADDER WAS SCANNED THERE WERE LARGE AMOUNTS OF URINE IN THE PATIENT'S BLADDER. ONCE THE CATHETER WAS REPOSITIONED AND MILKED, IT DRAINED 700CC OF URINE. THE COMPLAINANT STATED THE DRAINAGE ISSUES MAY NOT BE WITH THE CATHETER, HOWEVER POSSIBLY THE BLADDER.

  Patient problems: Urinary Retention

  MAUDE report 7594182 ↗
• 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 ↗

Other C. R. Bard, Inc. products

• Bardex I.C. Foley Catheter26 models · 3,607 reports
• Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
• Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
• Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
• Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
• Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
• PureWick Female External Catheter5 models · 1,184 reports
• Bardex All-Silicone Foley Catheter12 models · 1,170 reports