Bardia® Foley Catheter Insertion Tray 802010Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00801741018282), received between Jan 25, 2018 and Sep 25, 2025 — classified as 54 malfunctions.

The most frequently reported specific device problem is “Component Missing” (38 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 25 most recent of 54 reports, 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 ↗
• MalfunctionJun 20, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THREE OF THE KITS CAME WITHOUT A SALINE SYRINGE AND NONE HAVE ANY STERILE GLOVES. CONSUMER STATED THEY HAD TO OPEN THREE KITS JUST TO GET ONE SYRINGE FILLED WITH SALINE SOLUTION. PER CUSTOMER ON (B)(6) 2024, IT WAS REPORTED THAT TWO FOLEY TRAYS DID NOT CONTAIN SALINE SYRINGES. BOTH TRAYS WERE FROM THE SAME LOT AND LOT#NGHP2484 WAS REPORTED. THERE WAS NO PATIENT INVOLVED AND THE DEFECT WAS NOTICED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19574715 ↗
• MalfunctionMay 28, 2024Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE FOLEY CATHETER INSERTION TRAY REPLACEMENT INSERTION KIT DID NOT COME WITH GLOVES EITHER. PER ADDITIONAL INFORMATION RECEIVED VIA CUSTOMER FOLLOW UP ON 09MAY2024, IT WAS REPORTED THAT THEY RECEIVED A FOLEY TRAY THAT CONTAINED ALL CONTENTS INCLUDING THE GLOVES. THE ISSUE WAS THAT IT HAD A STICKER ON THE OUTER PACKAGE THAT SAYS NON-STERILE. CUSTOMER WAS CONCERNED AND DID NOT USE THE TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19404400 ↗
• MalfunctionMar 19, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THE FOLEY INSERTION TRAY WAS MISSING LUBRICATION. PATIENT WOULD LIKE A REPLACEMENT. PER CUSTOMER ON 05APR2024, IT WAS REPORTED THAT THEY WAS STILL USING THE DRAIN BAG, BUT IT WAS VERY UNCOMFORTABLE, AND THE PORT WAS PRESSING AGAINST PATIENT LEG. IT ALSO LEAKED AROUND THE AREA WHERE YOU DRAIN THE BAG, NO MEDICAL INTERVENTION WAS REPORTED. CUSTOMER RECOMMENDED THAT NEXT TIME A REP REACHES OUT FOR THEM TO PLACE A NEW ORDER, THEY WOULD LIKE TO SEE WAS THERE A MORE COMFORTABLE VARIATION OF THE DRAIN BAG THAT WON'T PRESS AGAINST PATIENT LEG. THEY ALSO EXPERIENCED RECEIVING A FOLEY TRAY THAT WAS MISSING LUBRICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18932810 ↗
• MalfunctionMar 8, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TIP OF THE 10CC SYRINGE BREAKING OFF INTO FOLEY AS THEY WERE PREPARING THE SALINE SOLUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18865359 ↗
• MalfunctionMar 5, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TIP OF THE 10CC SYRINGE WAS BREAKING OFF INTO THE FOLEY CATHETER AS THE PATIENT WAS PREPARING THE SALINE SOLUTION. PATIENT STATED THAT IT ALSO COMPROMISED THE SANITIZATION OF THE DRAIN BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838473 ↗
• MalfunctionJul 20, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PATIENT STATED THAT ONE OF THE ITEMS WAS PUNCTURED. THE HEAD HAD A PUNCTURE THROUGH THE TAP. PER FOLLOW UP VIA EMAIL RECEIVED ON (B)(6)2023, CUSTOMER STATED THAT NO ISSUE WITH A PATENT. THE PRODUCT ARRIVED WITH A PUNCTURE IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17364153 ↗
• MalfunctionMay 5, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE FOLEY CATHETER INSERTION TRAY SYRINGES WERE NOT PREFILLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875320 ↗
• MalfunctionApr 11, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THE FOLEY CATHETER INSERTION TRAY WAS MISSING THE BETADINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16712384 ↗
• MalfunctionOct 18, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE PREFILLED SYRINGE WAS MISSED IN THE INSERTION KITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15624631 ↗
• MalfunctionJul 18, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE IODINE SOLUTION WAS MISSING FROM THE FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15039784 ↗