SureStep™ Foley Tray System Bardex® IC Complete Care® A903316ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741096600), received between Mar 2, 2023 and Apr 17, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT FOLEY KIT WAS OPENED, THE 10 CC SYRINGE OF STERILE WATER ONLY HAD 1 CC OF WATER, NO CAP FOUND. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21854733 ↗
• MalfunctionMar 2, 2023Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE PATIENT WAS LATEX ALLERGY, LATEX FOLEY PLACED IN PATIENT. REPRESENTATIVE COULD NOT FIND ANY INDICATION ON FOLEY PACKAGE DOCUMENTING LATEX PRODUCT. RELIEF REPRESENTATIVE REMOVED THE FOLEY IMMEDIATELY BEFORE PROCEDURE BEGAN, BECAUSE THEY KNEW FROM EXPERIENCE THIS PRODUCT WAS IN FACT A LATEX PRODUCT. PATIENT SUSTAINED NO HARM. SURGEON OPTED TO DRAIN BLADDER WITH IN AND OUT CATHETER AT THE END OF PROCEDURE RATHER THAN PLACING A NON-LATEX FOLEY. AFTER EXAMINING OTHER FOLEY CATHETER KITS THE REQUIRED DOCUMENTATION OF LATEX PRODUCT WAS FOUND ON THE KIT, BUT THE FLAP SEAL WAS COVERING THE WRITING FROM IMMEDIATELY BEING SEEN, A PERSON WOULD HAVE TO KNOW WHERE TO LOOK AND MANEUVER THE PRODUCT INSIDE. SOME OF THE KITS HAD AN ADDITIONAL STICKER PLACED ON THEM THAT SAID THIS PRODUCT CONTAINS LATEX, BUT ALL KITS DID NOT HAVE A STICKER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16466954 ↗