SureStep™ Foley Tray System Bardex® All- Silicone Foley Catheter Tray A897516Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741073984), received between Feb 5, 2018 and Apr 22, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Component Missing” (4 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-3115-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Fracture

  IT WAS REPORTED THAT THEIR HOSPITAL HAD AN INCIDENT WITH SURESTEP FOLEY TRAY SYSTEM, LOT IS NGKX3708. THEY WERE LOOKING TO REPORT THIS EVENT AND ARE INTERESTED IF THERE ARE ONGOING ISSUES WITH THIS PRODUCT THAT HAVE BEEN REPORTED. REGISTERED NURSE WAS PLACING FOLEY INSERTED SALINE INTO BALLOON. WHEN ATTEMPTED TO FLUSH SALINE INTO BALLOON. THE SALINE SQUIRTED OUT THE SIDE OF THE SYRINGE. THE SYRINGE WAS CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958400 ↗
• MalfunctionJun 27, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT THE NURSE RECEIVED THE FOLEY CATHETER TRAY WITH BETADINE PACKET WHICH ONLY HAD 2 SWABS IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345543 ↗
• MalfunctionApr 18, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT FOLEY FELL OUT OF URETHRA DURING PRACTICE PUSH WITH PATIENT AND NO LONGER HAD FLUID IN WHERE BULB SHOULD BE. 10ML SYRINGE WAS USED WHEN PLACING CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21868625 ↗
• MalfunctionApr 17, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THEY HAD ANOTHER FOLEY EVENT THAT MORNING THAT THEY WANTED TO LET THEM ALL KNOW ABOUT BECAUSE THE 10 CC SALINE SYRINGE WAS BROKEN AND HAD SALINE LEAKED OUT OF IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855203 ↗
• MalfunctionOct 20, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT SYRINGE USED TO INFLATE BALLOON WAS EMPTY IN FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17975100 ↗
• MalfunctionAug 26, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT THE 100 CC STERILE WATER SYRINGE WAS MISSING FROM THE TRAY.

  Patient problems: No Patient Involvement

  MAUDE report 8932849 ↗
• MalfunctionApr 9, 2019Component Missing

  IT WAS REPORTED THAT UPON OPENING THE FOLEY CATHETER KIT, THE 10 ML PREFILLED STERILE WATER SYRINGE WAS MISSING.

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

  MAUDE report 8495037 ↗
• MalfunctionFeb 13, 2019Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE SYRINGE INSIDE OF THE SURESTEP FOLEY TRAY CONTAINED BLACK CONTAMINATED MATERIAL INSIDE OF IT.

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

  MAUDE report 8335091 ↗
• MalfunctionFeb 5, 2018Component Missing

  IT WAS REPORTED THAT THE FOLEY TRAY WAS MISSING THE POVIDONE-IODINE PACKET.

  Patient problems: No Information

  MAUDE report 7241706 ↗