SureStep™ Foley Tray System A304914Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741104350), received between Apr 16, 2024 and Sep 21, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 16, 2026.

Recalls naming this device

1. Jun 25, 2026Open, Classified

   Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

   Z-3114-2026 · 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.

• MalfunctionSep 21, 2026No Flow; Unintended Movement

  14 F coude cath that was placed and patient partially pulled out. It did not come out all of the way and RN went to pull the fluid from the balloon but it did not withdraw. Tried many different syringes and fluid still did not withdraw. Cut the catheter tubing as a last resort and fluid still did not come out of balloon.

  Patient problems: Insufficient Information

  MAUDE report 50838815 ↗
• MalfunctionApr 16, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT CUSTOMER RECEIVED A FOLEY TRAY WITH A SYRINGE WITH SOME DEBRIS INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19115982 ↗