SureStep™ Foley Tray System Bardex® I.C. Complete Care Foley Catheter A319414AMRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741073854), received between Jun 22, 2018 and Mar 31, 2023 — classified as 7 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-3116-2026 · 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.

• MalfunctionMar 31, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHEN THE NURSE WAS IN THE PROCESS OF INSERTION, THEY NOTICED THAT THE FOLEY WAS SEVERELY ADHERED TO THE DRAIN TUBING. WHEN IT WAS PEELED OFF OF EACH OTHER, THE FOLEY CATHETER HAD SOME HOLES ON IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16654892 ↗
• MalfunctionAug 21, 2020Crack; Fracture; Material Rupture; Fracture

  IT WAS REPORTED THAT WHEN INFLATING THE BALLOON, THE SYRINGE RUPTURED DUE TO A HAIRLINE CRACK. NEW FOLEY HAD TO BE OPENED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10440048 ↗
• MalfunctionSep 10, 2019Short Fill

  IT WAS REPORTED THAT THE SYRINGE WAS NOT FULL. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8983608 ↗
• MalfunctionNov 30, 2018Fluid/Blood Leak

  FOUR BARD FOLEY'S LEAKING FROM SEAL NEAR REFLUX PORT. ALL FOLEY'S HAD TO BE REPLACED WITH NEW FOLEYS CAUSING AN INCREASED RISK FOR CATHETER ASSOCIATED URINARY TRACT INFECTION FOR EACH PATIENT AND AN INCREASED COST. AT THIS TIME IT IS NOT KNOW IF ANY OF THESE PATIENTS EXPERIENCED AN INFECTION DUE TO THE ADDITIONAL FOLEY INSERTION REQUIRED FOLLOWING THESE LEAKING DEVICES. MANUFACTURER RESPONSE FOR CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES, SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® I.C. COMPLETE CARE FOLEY CATHETER (PER SITE REPORTER). MANUFACTURER RESPONSE FOR CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES, SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® I.C. COMPLETE CARE FOLEY CATHETER (PER SITE REPORTER). MANUFACTURER WILL BE SENDING BOXED TO THIS FACILITY TO SHIP BACK FOR INVESTIGATION.

  Patient problems: Urinary Tract Infection

  MAUDE report 8119666 ↗
• MalfunctionAug 30, 2018Gel Leak; Misassembled; Component Missing; Gel Leak; Misassembled

  IT WAS REPORTED THAT WHEN THE FOLEY TRAY WAS OPENED, THE SALINE SYRINGE WAS FOUND TO BE MISSING THE SALINE. ALLEGEDLY, THERE WAS NO CAP ON THE END OF THE SYRINGE.

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

  MAUDE report 7831600 ↗
• MalfunctionJul 20, 2018Leak/Splash

  AFTER VISUAL INSPECTION OF THE DEVICE, THE DEVICE WAS INSERTED INTO THE PATIENT. APPROXIMATELY 20 MINUTES AFTER, URINE BEGAN TO COLLECT INTO THE BAG, THE BAG BEGAN TO LEAK ONTO THE FLOOR. THE DEVICE HAD TO BE REMOVED AND ANOTHER DEVICE PLACED USING STERILE TECHNIQUE. THE DEVICE WAS RETAINED FOR INVESTIGATION; HOWEVER PACKAGING WAS DISCARDED. THERE IS NO KNOWN NEGATIVE IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7705916 ↗
• MalfunctionJun 22, 2018Deflation Problem; No Flow

  FOLEY WAS INSERTED WITHOUT ISSUE. IT WAS LATER NOTED THEY FOLEY WAS NOT DRAINING URINE FROM BLADDER. WHEN THERE WAS ATTEMPT TO DEFLATE BALLOON AND REMOVE FOLEY, THE BALLOON WOULD NOT DEFLATE. FOLEY HAD TO BE CUT TO REMOVE IT FROM PATIENT. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7632328 ↗