SureStep™ Foley Tray System Bardex® IC Complete Care® A300316ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741073731), received between Apr 18, 2017 and Mar 14, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Component Missing” (3 reports).

2 FDA recall records name this device's identifier, 2 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 ↗

2. Aug 5, 2021Class IIOpen, Classified

   There is potential for packaging defects that may impact the sterile barrier.

   Z-2523-2021 · Root cause: Packaging change control · 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.

• MalfunctionMar 14, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A FOLEY CATHETER ASSESSMENT, THE SURESTEP FOLEY TRAY ONLY HAD 2 FOAM SWAB STICKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21605305 ↗
• MalfunctionOct 22, 2024Gel Leak; Gel Leak

  IT WAS REPORTED THAT FOLEY TRAY WAS USED BUT THEY HAD TO PULL ANOTHER LUBRICATE, DUE TO THE ONE IN THE FOLEY KIT WAS DRIED UP. PER ADDITIONAL INFORMATION RECEIVED ON 09OCT2024, IT WAS REPORTED THAT THE LUBRICATED JELLY SYRINGE LOW OR DRY. PER CUSTOMER FOLLOW UP ON 10DEC2024, IT WAS REPORTED THAT NOT THE LUBE, BUT THE CLINICAL TEAM PULLED A DIFFERENT LUBE TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506186 ↗
• MalfunctionMay 4, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE FOLEY TRAY HAD 2 SYRINGES WITH LUBRICANT INSTEAD OF ONE AND WAS MISSING THE SYRINGES WITH SALINE FOR BALLOON INFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14277955 ↗
• MalfunctionDec 27, 2018Nonstandard Device; Nonstandard Device; Material Integrity Problem

  IT WAS REPORTED THAT THE POVIDONE IODINE SWABSTICKS WERE NOT SATURATED ENOUGH. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8200878 ↗
• MalfunctionSep 27, 2018Misassembled; Manufacturing, Packaging or Shipping Problem; Misassembled

  IT WAS REPORTED THAT THE SYRINGE DID NOT HAVE AN OPENING.

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

  MAUDE report 7913909 ↗
• MalfunctionJun 6, 2017Component Missing

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6616190 ↗
• MalfunctionApr 18, 2017Component Missing

  IT WAS REPORTED THAT THE FOLEY TRAY WAS MISSING LUBRICANT AND THE 10CC SALINE SYRINGE.

  Patient problems: No Patient Involvement

  MAUDE report 6501321 ↗