SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter A902918Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741074080), received between Jan 9, 2020 and Dec 7, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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-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.

• MalfunctionDec 7, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT CUSTOMER ORDERED FOLEY CATHETER, ONE SYRINGE IN THE ONE KIT DID NOT HAVE SALINE INSIDE OF IT AND THEY DID OPEN THREE OTHER KITS AND THE SYRINGES INSIDE ALL HAD FLUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282145 ↗
• MalfunctionJan 9, 2020Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE TUBING ON THE DRAIN BAG KINKED. THE COMPLAINANT NOTED THAT THE SHEET CLIP WAS NOT ON THE BAG AND WHEN IT WAS PLACED, THE KINK STRAIGHTENED OUT A LITTLE.

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

  MAUDE report 9571745 ↗