Bardia Foley Catheter Insertion TrayRecalls & reported problems across all models

We found 4 models of Bardia Foley Catheter Insertion Tray by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 82 adverse event reports in the FDA's MAUDE database, received between Jun 29, 2017 and Sep 25, 2025 — classified as 8 injuries, 74 malfunctions.

The most frequently reported specific device problem is “Component Missing” (59 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. 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

Most reported Bardia Foley Catheter Insertion Tray problems

Bardia Foley Catheter Insertion Tray models

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

• Bardia® Foley Catheter Insertion Tray 802010

  Catheter care tray
  54 reports
• Bardia® Foley Catheter Insertion Tray 802110

  Catheter care tray
  19 reports
• Bardia® Foley Catheter Insertion Tray 802030

  Catheter care tray
  6 reports
• Bardia® Foley Catheter Insertion Tray 802130

  Catheter care tray
  3 reports

Recent Bardia Foley Catheter Insertion Tray adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2025Component Missing; Defective Device; Component Missing; Defective Device

  PT SAID THAT THESE WERE DEFECTIVE. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. USED WITH FEMALE WICKS. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23142552 ↗
• MalfunctionAug 25, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT SAID THAT THERE WERE ISSUES BEFORE. REP REPLACED. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22884288 ↗
• MalfunctionAug 12, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT THE PT STATED INSERTION TRAY DOESN'T HAVE THE SYRINGE. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783200 ↗
• MalfunctionJul 2, 2025Short Fill; Short Fill

  IT WAS REPORTED THAT EMPTY SYRINGES IN FOLEY TRAY. PER FOLLOW UP RESPONSE RECEIVED VIA EMAIL ON 12JUL2025, NO SAMPLES WERE AVAILABLE, SALINE WAS SENT OUT TO THE PATIENT SO THE SYRINGES COULD BE FILLED AS USED. THE PATIENT NO LONGER HAD THE ITEM PACKAGING. NO MAJOR IMPACT, ALTERNATE ITEM WAS PROVIDED. CUSTOMER REACHED OUT TO THEIR VENDOR CARDINAL HEALTH TO CONFIRM IF THEY HAD ANY CHANGES MADE TO THE ITEM ON THEIR END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383941 ↗
• MalfunctionJun 5, 2025Gel Leak; Gel Leak

  IT WAS REPORTED THAT THE BALLOON FILL SYRINGE AND IODINE WERE OPENED AND EMPTIED EITHER BY PUNCTURE OR SOMETHING AND THE STERILE GLOVES WERE NOT STERILE AND EVEN ON THE THIRD ONE THE GLOVE(S) RUPTURED AS PATIENT WAS PULLING THEM ONTO THEIR HAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22149055 ↗
• MalfunctionJun 4, 2025Gel Leak; Gel Leak

  IT WAS REPORTED THAT THE BALLOON FILL SYRINGE AND IODINE WERE OPENED AND EMPTIED EITHER BY PUNCTURE OR SOMETHING AND THE STERILE GLOVES WERE NOT STERILE AND EVEN ON THE THIRD ONE THE GLOVE(S) RUPTURED AS PATIENT WAS PULLING THEM ONTO THEIR HAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22141175 ↗
• MalfunctionJun 2, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT THE PATIENT DID NOT RECEIVE SYRINGE IN THE FOLEY INSERTION TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122683 ↗
• MalfunctionApr 10, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT THE CUSTOMER STATED THE MOST RECENT ORDER (B)(4) ITEM 57802010 DID NOT HAVE A SYRINGE WHICH THEY NEED TO INSERT THE CATHETERS. PER CUSTOMER VIA PHONE ON 02APR2025, IT WAS REPORTED THAT CUSTOMER RECEIVED FOLEY'S WITH THE MISSING SYRINGES. THE ISSUE WAS RESOLVED. NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21813671 ↗
• MalfunctionMar 24, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT KIT DIDN'T HAVE THE LUBE OR IODINE. THEY DID NOT HAVE LOT NUMBER. PER CUSTOMER VIA PHONE ON 20MAR2025, IT WAS REPORTED THAT THE FOLEY WAS MISSING THE IODINE AND THE LUBRICANT THAT SHOULD HAVE BEEN IN THE PACKAGING. THEY THREW THE FOLEY AND THE CONTENTS AWAY. NO LOT NUMBER IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676320 ↗
• MalfunctionJan 8, 2025Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT IN ONE FOLEY CATHETER KIT THE BALLOON WOULD NOT INFLATE. PER CUSTOMER VIA PHONE ON 19DEC2024, IT WAS REPORTED THAT CAREGIVER ATTEMPTED TO INSERT A FOLEY CATHETER AND THE BALLOON WOULD NOT INFLATE. IT WAS NOTED THAT THE TUBING THAT WOULD USUALLY ALLOW URINE FLOW SEEMED TO BE SEALED CLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21101584 ↗
• MalfunctionDec 6, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT PATIENT STATED THE FOLEY TRAYS DID NOT HAVE ANY SALINE IN THEM. PER CUSTOMER FOLLOW UP RECEIVED ON 14DEC2024, LIBERATOR RESOLVED THIS ISSUE AND WANTED TO CLOSE THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20864057 ↗
• MalfunctionOct 10, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THE BARDIA FOLEY CATHETER INSERTION TRAY WAS MISSING SYRINGE, IT ONLY CAME WITH A URINE CUP. PATIENT CANNOT USE URINE CUP AND CAN ONLY USE A SYRINGE TO FILL FOLEY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20416739 ↗
• MalfunctionSep 10, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT CUSTOMER ASKED IF THE SYRINGES WERE REFILLED WITH A NUMBING AGENT BECAUSE WHEN THEY FOLEY WAS CHANGED AT THE PROVIDERS OFFICE THEY USE A SYRINGE WITH A NUMBING AGENT AND KIT WAS MISSING THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181070 ↗
• MalfunctionJul 8, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT SALINE WAS MISSING FROM THE SYRINGE IN A FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19688287 ↗
• MalfunctionJul 1, 2024Short Fill; Short Fill

  IT WAS REPORTED THAT CUSTOMER OPENED MULTIPLE PACKAGES OF FOLEY TRAY FROM THE LOT THAT WAS MISSING SALINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19642931 ↗

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