SureStep™ Foley Tray System Bardex® Lubricath® Coude Foley Catheter A304918Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741100499), received between Jan 23, 2019 and Feb 19, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2020Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Device Markings/Labelling Problem

  IT WAS REPORTED BY THE FACILITY THAT A PATIENT WITH A KNOWN LATEX ALLERGY WAS CATHETERIZED WITH A SURESTEP TRAY BECAUSE THE NURSE DID NOT SEE A LATEX ALLERGY WARNING LABEL. NO MEDICAL INTERVENTION WAS REPORTED. THE FACILITY REPORTED THAT THE PLACEMENT OF THE WARNING PORTION OF THE LABEL WAS HIDDEN ON THE PACKAGE. IT WAS SUGGESTED THAT THE WARNING LABEL BE REPEATED ON THE LARGER PORTION OF THE LABEL, USING A COLOR DIFFERENT FROM THE OTHER LETTERING.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 9729381 ↗
• MalfunctionMar 28, 2019Misassembled; Component Missing; Misassembled

  IT WAS REPORTED THAT THE FOLEY CATHETER DID NOT HAVE ANY EYELETS IN THE TIP. THE CATHETER WAS REMOVED FROM THE PATIENT AND REPLACED. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8459749 ↗
• MalfunctionJan 23, 2019Difficult to Flush; Material Invagination; Material Integrity Problem; Material Invagination

  IT WAS REPORTED THAT THE FOLEY BALLOON WOULD NOT FLUSH. UPON REMOVAL, THE DEVICE WAS FOUND MUSHROOMED AND AS A RESULT, THERE WAS BLOOD IN THE URINE OUTPUT. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8271516 ↗