SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter Tray A942214Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741074103), received between Dec 5, 2018 and Jan 27, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Component Missing” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2025

  FOLEY CATHETER WOULD NOT EMPTY INTO CANISTER. ON INSPECTION, IT WAS FOUND THAT THE INSIDE OF THE BAG WAS ADHERED TO THE TUBE WHERE THE URINE WAS SUPPOSED TO EMPTY, WHEN REGISTERED NURSE (RN) TRIED TO PULL BAG AWAY FROM THE TUBE TO ALLOW URINE TO DRAIN, THE BAG TORE. NO HARM TO THE PATIENT OR THE NURSE WAS REPORTED. THE FOLEY WAS DISCONTINUED WITHOUT ANY FURTHER ISSUES. THE DEFECTIVE FOLEY WAS DISCARDED BY STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21240033 ↗
• MalfunctionNov 19, 2024

  FOLEY BALLOON POOPED DURING INFLATING BALLOON.

  Patient problems: Insufficient Information

  MAUDE report 20722619 ↗
• MalfunctionMay 14, 2024

  PATIENT HAD FOLEY CATHETER PLACED DURING DAY SHIFT DUE TO INCREASES IN BLEEDING AND INABILITY TO VOID POST PARTUM. UPON SHIFT CHANGE, FOLEY CATHETER WAS DRAINING APPROPRIATELY. WHEN THIS RN RETURNED IN AM , NIGHT SHIFT RN, REPORTED FEELING PATIENTS UTERUS DEVIATED TO THE RIGHT, CHECKING URINE OUTPUT, NOTICED THERE WAS NO OUTPUT IN THE FOLEY BAG, ASSESSED AND ADJUSTED THE TUBING. NIGHT SHIFT RN STATED THAT URINE THEN STARTED TO COLLECT IN FOLEY BAG AND SHE WAS ABLE TO DRAIN 1100ML OUT AT THAT TIME. UPON AM ASSESSMENT, A COUPLE OF HOURS AFTER NIGHT SHIFT RN EMPTIED FOLEY, THIS RN NOTICED THERE WAS NO URINE OUTPUT IN THE BAG. THIS RN ADJUSTED THE TUBING, NO KINKS OR DEPENDENT LOOPS NOTED, WAS ABLE TO GET 600ML OF URINE TO DRAIN. FUNDUS FIRM AND MIDLINE. THIS RN ATTEMPTED TO EMPTY BLADDER FULLY BEFORE REMOVING FOLEY, PER PREVIOUSLY WRITTEN ORDER. FOLEY CATHETER SET ASIDE IN RED BIOHAZARD BAG WITH PATIENT LABEL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Urinary Retention

  MAUDE report 19310227 ↗
• MalfunctionMay 6, 2021Gel Leak; Gel Leak

  IT WAS REPORTED THAT THE CUSTOMER OPENED THE TRAY TO PREPARE FOR INSERTION AND A WET LOOKING SPOT WAS NOTED ON THE OUTER STERILE WRAPPER. ALSO NOTED THAT THE STOPPER END OF A SYRINGE OF KY JELLY WAS OFF WHICH RESULTED IN CONGEALING OF KY JELLY ON THE OUTSIDE OF THE SYRINGE AND DIFFERENT PARTS OF THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11784529 ↗
• MalfunctionApr 1, 2020Component Missing

  IT WAS REPORTED THAT UPON OPENING THE SURESTEP FOLEY TAY KIT, THERE WAS NOT AN IODINE SACHET PRESENT. IT WAS FOUND DURING A HOSPITAL ICU STAFF DEMONSTRATION.

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

  MAUDE report 9914240 ↗
• MalfunctionJan 31, 2020Component Missing

  IT WAS REPORTED THAT THE CATHETER TRAY WAS MISSING A CATHETER.

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

  MAUDE report 9653640 ↗
• MalfunctionDec 5, 2018Appropriate Device Problem Term/Code Not Available

  A FOLEY (URINARY) CATHETER EXPULSED DURING A CAESARIAN SECTION PROCEDURE. THE BALLOON WAS INTACT. MANUFACTURER RESPONSE FOR SURESTEP FOLEY CATHETER TRAY, SURESTEP (PER SITE REPORTER) WE MET WITH THE MANUFACTURER REPRESENTATIVES ABOUT THIS AND SEVERAL OTHER FAILURES OF FOLEY CATHETERS. THE MANUFACTURER REPRESENTATIVE NOTED THERE IS AN IDENTIFIED PROBLEM WITH THE VENT OF THE NEW DESIGN OF THE SURESTEP FOLEY CATHETER SYSTEM. THEY HAVE REVERTED BACK TO THE PRIOR VENTLESS PRODUCT ALTHOUGH THERE ARE STILL SOME VENTED CATHETERS AVAILABLE IN THE SUPPLY STREAM. WE GAVE THE REPRESENTATIVE SEVERAL OTHER CATHETERS AND WILL AWAIT ANALYSIS BY THE MANUFACTURER'S QUALITY DEPT.

  Patient problems: No Information

  MAUDE report 8132449 ↗