Bard® Foley Tray with Bardex® All Silicone Foley Catheter 897216Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741020322), received between Feb 15, 2019 and Jun 24, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Component Missing” (4 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.

• MalfunctionJun 24, 2025Disconnection; Material Fragmentation; Disconnection; Material Fragmentation

  IT WAS REPORTED THAT FOLEY TRAY HANDLE BROKE OFF. IT WAS NOTED THAT THE GIVEN LOT# WAS NGJZ2064.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22324973 ↗
• MalfunctionJan 8, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT BARD LATEX-FREE FOLEY TRAY KIT FAILED. FOLEY KIT SALINE SYRINGE ONLY HAD 3MLS IN SYRINGE. NO STAT-LOCK IN THE KIT. THE FOLEY TUBE ATTACHED TO THE BAG WAS CRACKED AND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21101828 ↗
• MalfunctionApr 25, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT FOLEY KITS WERE MISSING THE STERILE WATER SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19180023 ↗
• MalfunctionFeb 28, 2023Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional

  IT WAS REPORTED THAT THE FOLEY CATHETER KITS CAME WITH A 10ML SALINE SYRINGE TO INFLATE THE BALLOON WITH INSTRUCTIONS TO INFLATE ALL 10MLS. THEIR STUDENTS FOLLOWED THESE INSTRUCTIONS, HOWEVER, THE BALLOONS ALL RUPTURED INSIDE OF THEIR MANNEQUINS. WHEN THEY WENT TO ASSIST AND NOTED THAT THE FOLEY BALLOONS INCLUDED WITH THE KITS WERE ONLY 5ML CAPACITY. THEREFORE, THERE WERE MISLEADING OR INACCURATE INSTRUCTIONS AND INCOMPATIBLE SUPPLIES PROVIDED WITH THIS KIT AND THEY HAD TO DISASSEMBLE THE MANNEQUINS AND REMOVE THE SALINE NOW INSIDE OF THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16451792 ↗
• MalfunctionNov 19, 2021Material Invagination; Material Invagination

  IT WAS REPORTED THAT UPON REMOVING THE FOLEY CATHETER, THE BALLOON WAS DEFLATED BUT IF THERE WAS ANY PRESSURE AGAINST THE BALLOON DURING THIS STEP, A FOLD WILL OCCUR IN THE SILICONE CIRCUMFERENTIALLY. THIS PREVENTED THE FOLEY CATHETER FROM BEING REMOVED. THIS HAD HAPPENED MULTIPLE TIMES WITH BOTH THE TRAY PRODUCT NUMBER 897216 AND WITH TRAY PRODUCT NUMBER 947316. AND ONE PATIENT NEEDED TO GO TO HAVE A PROCEDURE TO REMOVE THE CATHETER. THE CUSTOMER STATED THAT THEY HAVE A LARGE NUMBER OF THESE FOLEY TRAYS THAT WERE NOT WORKING FOR THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12846953 ↗
• MalfunctionJul 28, 2021Inflation Problem

  FOLEY CATHETER INSERTED PER DOCTOR'S ORDER. 3 ML INITIALLY INSTILLED TO TEST BALLOON. FOLEY INSERTED WITHOUT DIFFICULTY. ATTEMPTED TO INFLATE THE BALLOON TO 10 ML PER DEVICE INSTRUCTIONS, 3 ML AGAIN INSTILLED, BUT MET RESISTANCE AND UNABLE TO BLOW UP BALLOON FULLY. BALLOON DEFLATED BUT 2 ML REMAINED IN BALLOON AND UNABLE TO BE REMOVED, DOCTOR MADE AWARE. FOLEY REMOVED, ATTEMPTED TO RE INSTILL 10 ML ONCE REMOVED, STILL MET RESISTANCE AT THE HUB AND UNABLE TO BLOW UP BALLOON AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12239916 ↗
• MalfunctionOct 23, 2020Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED 18FR FOLEY TRAY INSTEAD OF THE 16FR TRAY.

  Patient problems: No Patient Involvement

  MAUDE report 10727746 ↗
• MalfunctionOct 17, 2019Deflation Problem

  IT WAS REPORTED THAT THE FOLEY PREMATURELY DEFLATED AFTER 10 DAYS OF USE. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 9202552 ↗
• MalfunctionFeb 15, 2019Component Missing

  IT WAS REPORTED THAT THE SILICONE CATHETER TRAY WAS MISSING THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8344494 ↗
• MalfunctionFeb 15, 2019Component Missing

  IT WAS REPORTED THAT THE SILICONE CATHETER TRAY WAS MISSING THE LUBRICATION SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8344472 ↗