SureStep™ Foley Tray System Bardex® IC Complete Care® A304716ARecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741104299), received between Mar 29, 2019 and Aug 12, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Misassembled” (3 reports).

2 FDA recall records 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 ↗

2. Apr 15, 2020Class IITerminated

   There is potential for a white paper-type residue attached to the catheter.

   Z-1970-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT CUSTOMER ORDERED 2 CASES OF SAMPLES OF COUDE BARDEX IC FOLEYS. CUSTOMER HAD NOT OPENED EACH TRAY BUT SO FAR 2 OUT OF EACH BOX WERE STANDARD LATEX AND NOT BARDEX IC FOLEY. PER FOLLOW UP RECEIVED VIA EMAIL ON 16SEP2025 STATED THAT THEY WERE NEVER IN CONTACT WITH A PATIENT. THEY STILL HAD THE UNOPENED FOLEYS. THEY RECEIVED A RETURN BOX BUT AND NOT SURE IF THEY WOULD ALL FIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783186 ↗
• InjuryJun 23, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT'S FOLEY CATHETER WAS NOTED TO BE OUTSIDE OF THE URETHRA. NO VISIBLE TRAUMA TO THE URINARY MEATUS. INDWELLING FOLEY CATHETER TIP WAS NOT INTACT. THE URINARY MEATUS WAS ASSESSED, NO INDWELLING CATHETER TIP PRESENT. MD AND CHARGE NURSE IMMEDIATELY NOTIFIED. X-RAY NEGATIVE FOR FOREIGN BODY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22308650 ↗
• MalfunctionFeb 7, 2024

  REGISTERED NURSE TESTED THE BALLOONS PRIOR TO INSERTION AND BOTH BALLOONS INFLATED BUT DID NOT DEFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18659541 ↗
• MalfunctionJul 5, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT THEY HAD A FOLEY KIT THAT HAD THE LUBE SYRINGE IN THE PACKAGING BUT IT HAD LESS THAN 1CC OF LUBE IN THE SYRINGE. THEY DID NOT OPEN ANOTHER KIT BECAUSE THEY WERE ABLE TO JUST GRAB A PACK OF LUBE SINCE THAT WAS THE ONLY PROBLEM. ALSO STATED THAT IT HAD ALREADY BEEN DISPOSED OF AND HAD 1 OTHER 16F LATEX, COUDE, FOLEY KIT IN THIS CLOSET. THE LOT # ON THAT ONE IS NGHP1924. HOWEVER THEY DID NOT KNOW IF THEY HAD THE SAME LOT #

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17255258 ↗
• MalfunctionFeb 8, 2020Misassembled; Packaging Problem; Misassembled

  IT WAS REPORTED THAT THE CATHETERS WERE PACKAGED INCORRECTLY.

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

  MAUDE report 9684971 ↗
• MalfunctionFeb 5, 2020Misassembled; Component Missing; Misassembled

  IT WAS REPORTED THAT THE CATHETERS IN THE KITS WERE MISPLACED. THIS ISSUE WAS NOTED PRIOR TO USE.

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

  MAUDE report 9671863 ↗
• MalfunctionJan 24, 2020Misassembled; Packaging Problem; Misassembled

  IT WAS REPORTED THAT THE CATHETERS IN THE KITS WERE MISPLACED.

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

  MAUDE report 9629345 ↗
• MalfunctionNov 5, 2019Material Twisted/Bent; Output below Specifications

  IT WAS REPORTED THAT THERE WAS LOW OUTPUT OBSERVED OVER LONG PERIODS. THE NURSING PRACTICE COUNCIL RAISED AND LOWERED THE TUBING AND INCREASED GRAVITY TO DRAIN. THE TUBING BENT AT THE JUNCTION. IT WAS DIFFICULT TO DRAIN, BUT THERE WERE NO BLOCKAGES.THERE WERE 4 KITS USED. PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON (B)(6)2019 , THE TUBING THAT WAS MANIPULATED WAS BETWEEN THE BAG AND THE CATHETER.

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

  MAUDE report 9282603 ↗
• MalfunctionMar 29, 2019Short Fill; Component Missing; Short Fill

  IT WAS REPORTED THAT THE SYRINGE INSIDE OF THE KIT HAD NO WATER.

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

  MAUDE report 8467210 ↗