Bardex® I.C. Complete Care® Foley Catheter Tray 300316ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741024344), received between Jun 8, 2018 and Nov 11, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (2 reports).

1 FDA recall record name this device's 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, 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.

Recalls naming this device

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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT CUSTOMER OPENED FOLEY TRAY IN PREPARATION FOR SURGICAL CASE. NURSE NOTED ON INSPECTION THAT THE AQUAFLATE STERILE WATER SYRINGE TO INFLATE THE BALLOON ON THE CATHETER HAD BLACK MATERIAL FLOATING INSIDE. CATHETER KIT WAS DISCARDED, AND ANOTHER KIT WAS OBTAINED AND INSPECTED. THE NEW KIT WAS FOUND TO BE GOOD WITHOUT ANY MATERIAL INSIDE THE SYRINGE OF STERILE WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20651770 ↗
• MalfunctionJan 18, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT NURSE WAS INFLATING THE FOLEY CATHETER WHEN THE TIP BROKE OFF. NO PATIENT HARM. PER FOLLOW UP VIA PHONE ON 06JAN2023, IT WAS THE TIP OF THE SYRINGE THAT BROKE. NO INJURY WAS CAUSED. PER ADDITIONAL INFORMATION RECEIVED VIA FORM WITH SAMPLE RETURNED ON 23JAN2023, NURSE REPORTED THAT WHEN THEY WENT TO INFLATE BALLOON THAT THE TIP OF THE SYRINGE SNAPPED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16193877 ↗
• MalfunctionApr 22, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT STATED AS ONE OF THE CATHETER WAS CLOGGED WITHIN THE FIRST THREE DAYS. THE KITS WERE DEFECTIVE AND THIS HAD NEVER HAPPENED BEFORE. ALSO EXPLAINED THAT THE KIT CONTAINING THE STATLOCK WAS NOT FUNCTIONING PROPERLY, THE ADHESION TO THE CLIP WAS DEFICIENT AND IT KEPT COMING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11711583 ↗
• MalfunctionAug 21, 2019Misassembled; Obstruction of Flow; Misassembled

  IT WAS REPORTED THAT THE HUB THAT ALLOWS URINE TO DRAIN INTO THE BAG WAS SEALED CLOSED. REPORTEDLY, THE PATIENT FELT A STRONG URGE TO VOID AND COULD NOT. THE NURSE CAME AND FLUSHED THE CATHETER THINKING THAT WAS THE ISSUE, TO NO AVAIL. ULTIMATELY, THE CATHETER WAS REMOVED AND REPLACED.

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

  MAUDE report 8917067 ↗
• MalfunctionMar 26, 2019Gel Leak; Device Contamination with Chemical or Other Material; Gel Leak

  IT WAS REPORTED THAT YELLOW LUBRICANT MATERIAL WAS FOUND INSIDE THE FOLEY TRAY. THE LUBRICANT, STERILE WATER, AND IODINE WERE SEALED UPON OPENING THE TRAY.

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

  MAUDE report 8453916 ↗
• MalfunctionJul 23, 2018Component Missing

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS MISSING FROM THE FOLEY TRAY. THE TRAY COULD NOT BE USED.

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

  MAUDE report 7711723 ↗
• MalfunctionJun 8, 2018Short Fill

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE OF THE FOLEY TRAY, IT WAS NOTED THAT THE STERILE WATER SYRINGE WAS SHORT 6ML.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 7584500 ↗