SureStep™ Foley Tray System Bard® Lubricath Foley A800360Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741073922), received between May 29, 2018 and Dec 21, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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. Aug 5, 2021Class IIOpen, Classified

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

   Z-2530-2021 · Root cause: Packaging change control · 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.

• MalfunctionDec 21, 2018Disconnection; Disconnection; Detachment of Device or Device Component; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT UPON OPENING THE SURESTEP FOLEY TRAY, IT WAS FOUND THAT THE CAP CAME OFF OF THE SYRINGE AND AN AMBER COLORED STICKY SUBSTANCE WAS IN THE TRAY. THE TRAY WAS NOT USED AND THE SYRINGE WILL BE RETUNED FOR INVESTIGATION. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 8189538 ↗
• MalfunctionSep 11, 2018Deflation Problem; Inflation Problem; Material Puncture/Hole; Deflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON HAD A HOLE IN THE BASE; THEREFORE IT COULD NOT BE INFLATED TO MAINTAIN CATHETER PLACEMENT. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 7864138 ↗
• InjuryMay 29, 2018Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE PRODUCTS IN THE FOLEY TRAY CONTRIBUTED TO A RECENT ANAPHYLACTIC LATEX ALLERGIC REACTION IN THE OR. THE COMPLAINANT REPORTED THAT THE OR TEAM WAS AWARE OF THE LATEX ALLERGY, BUT DID NOT SEE ANYTHING ON THE BARD FOLEY TRAY LABEL SO IT WAS ASSUMED THAT THE PRODUCT WAS A LATEX FREE TRAY. THE COMPLAINANT SUGGESTED THAT THE LABELING ON THE PACKAGE SHOULD BE CHANGED TO HIGHLIGHT THOSE TRAYS THAT CONTAIN LATEX PRODUCTS, OR MAKE THE LATEX WARNING LARGER AND EASIER TO READ. THE PATIENT EXPERIENCED A FULL HEMODYNAMIC COLLAPSE, SECONDARY TO THE ANAPHYLACTIC REACTION. THE PATIENT WAS GIVEN SEVERAL DOSES OF EPINEPHRINE, STEROIDS, FLUID RESUSCITATION, BENADRYL AND EPHEDRINE. THE PATIENT WAS PLACED ON A VENT FOR OVER 24 HOURS IN THE ICU UNIT. THE PATIENT WAS DISCHARGED TO AN EXTENDED CARE FACILITY DUE TO WEAKNESS. THE PATIENT HAS A HISTORY OF ANAPHYLACTIC REACTIONS TO LATEX.

  Patient problems: Anaphylactic Shock; Collapse; Reaction; Vascular System (Circulation), Impaired

  MAUDE report 7550867 ↗