Bard® Foley Tray with Bardex® Lubricath® Foley Catheter 899616Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741000287), received between Aug 25, 2017 and Oct 8, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Component Missing” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE FOLEY PLACED PRE-PROCEDURE (C-SECTION), AFTER PROCEDURE CATHETER WAS FOUND LYING IN BED. NURSE HAD FILLED BALLOON AS NORMAL. WHEN THEY LOOKED AT THE CATHETER THERE WAS NO ONE-WAY VALVE. NURSE STATES THIS HAD HAPPENED ONCE BEFORE. NEITHER ITEM WAS SAVED FOR INVESTIGATION. PER FOLLOW UP INFORMATION RECEIVED ON 09DEC2025, IT WAS REPORTED THAT NO PATIENT HARM WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23246269 ↗
• MalfunctionNov 21, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT CUSTOMER JUST RECEIVED FOLEY TRAY. THEY OPENED TWO OF THE KITS OF THE SWABS AND THERE WAS NO IODINE ON THE SWABS. THEY PURCHASED FROM EDGE PARK, BUT THEY REFUSED TO REPLACE, AND THEY HAD TO DISPOSE BECAUSE THE PRODUCT WAS NO LONGER STERILE. CUSTOMER REQUESTED REPLACEMENT OF 2 KITS TRAY1 & TRAY2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20749262 ↗
• MalfunctionNov 21, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT CUSTOMER JUST RECEIVED FOLEY TRAY. THEY OPENED TWO OF THE KITS OF THE SWABS AND THERE WAS NO IODINE ON THE SWABS. THEY PURCHASED FROM EDGE PARK, BUT THEY REFUSED TO REPLACE, AND THEY HAD TO DISPOSE BECAUSE THE PRODUCT WAS NO LONGER STERILE. CUSTOMER REQUESTED REPLACEMENT OF 2 KITS TRAY1 & TRAY2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20747982 ↗
• MalfunctionNov 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT CATHETER HAD A DEFECT IN THE BALLOON INFLATION SYRINGE. SYRINGE WAS CRACKED AND THE BALLOON INFLATION LIQUID WAS LEAKING. PER FOLLOW UP INFORMATION RECEIVED ON 07NOV2024, PATIENT REQUIRED ANOTHER INSERTION OF CATHETER AS THIS FAULTY WHICH INCREASED THE RISK OF INFECTION.

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

  MAUDE report 20621575 ↗
• MalfunctionOct 11, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CUSTOMER RAN INTO AN ISSUE TODAY WITH 2 TRAYS/CATHETERS THAT WOULD NOT DEFLATE. BOTH WERE FROM LOT #NGHR0219. NO ISSUES HAVE BEEN REPORTED WITH OTHER LOT NUMBERS AT THIS TIME. THEY CURRENTLY HAD 18 OF LOT# NGHR0219 STORED IN OUR SUPPLY WAREHOUSE AND AT LEAST 5 STAGED IN CLINICAL AREAS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17912345 ↗
• MalfunctionMar 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAK FROM THE FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16459063 ↗
• MalfunctionFeb 28, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED FOLEY TRAY WITHOUT COTTON BALLS OR POVIDONE-IODINE (PVI).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16451975 ↗
• MalfunctionAug 30, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE PATIENT DID NOT RECEIVE THE INSERTION SUPPLIES CAME ALONG WITH THE FOLEY TRAY KIT AND THEY RECEIVED ONLY A CATHETER AND DRAIN BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12387874 ↗
• MalfunctionDec 18, 2018Misassembled; Loss of or Failure to Bond; Misassembled; Component Missing

  IT WAS REPORTED THAT THE TUBING COULD NOT BE ATTACHED TO THE CATHETER, AS THE EZ-LOK SAMPLE PORT WAS MISSING. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8173369 ↗
• MalfunctionAug 25, 2017Fluid/Blood Leak

  IT WAS REPORTED THAT THE BETADINE WITHIN THE TRAY HAD LEAKED ALL OVER THE INSIDE OF THE TRAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6819934 ↗