SureStep™ Foley Tray System with Bard® Lubri-Sil® Catheter A942206Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741100543), received between Nov 27, 2023 and Feb 25, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 25, 2026Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Difficult to Remove

  IT WAS REPORTED THAT AFTER INSERTING THE FOLEY CATHETER TO THE PATIENT IN THE OPERATING ROOM, WATER COULD NOT BE INFUSED, AND LEAKAGE WAS CONFIRMED FROM THE VALVE, SO REMOVAL WAS DECIDED. THEN TRIED TO WITHDRAW WATER USING A SYRINGE, BUT IT COULD NOT BE DRAWN AT ALL. THE CATHETER WAS REMOVED, LEAVING A SMALL AMOUNT OF STERILE WATER REMAINING. NO BLEEDING OR OTHER ISSUES WERE OBSERVED. THE TROUBLESHOOTING PROCEDURE IN THE NOTICE DOCUMENT WAS TRIED AND STILL NOT ABLE TO WITHDRAW WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24446108 ↗
• MalfunctionAug 12, 2025Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT THE CUSTOMER STATED THEY HAD A BALLOON RUPTURE OF THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22785336 ↗
• MalfunctionApr 30, 2024Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT CUSTOMER HAD INCIDENT ON (B)(6) 2024 WITH FOLEY CATHETER WITH PENDING INFORMATION AND ON (B)(6) 2024, FOLEY CATHETER WAS INSERTED ON A PATIENT, UPON INFLATING THE BALLOON TO THE PRESCRIBED 1.5 ML, THEY GENTLY TUGGED TO ENSURE PATENCY, BUT THE ENTIRE CATHETER CAME OUT OF THE PATIENT, AND THE BALLOON WAS NOT INFLATED AT ALL. THEY INSPECTED THE FOLEY BALLOON BY INJECTING MORE FLUID AND NOTICED THAT THE FLUID WAS LEAKING FROM THE BALLOON AREA. ANOTHER FOLEY OF THE SAME SIZE WAS INSERTED. MD AND ANESTHESIA, AND SUPERVISOR AWARE OF THE INCIDENT AND THERE WAS THIRD INCIDENT WITH PENDING INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212536 ↗
• MalfunctionFeb 6, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE 6 FR FOLEY CATHETER WAS USED IN PATIENT. WHILE CARING FOR PATIENT, THE CATHETER HAD COME OUT AND NOTED THAT THE BALLOON WAS POPPED/NOT INTACT. NEW FOLEY CATHETER HAD TO BE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18649274 ↗
• MalfunctionDec 7, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE BALLOON OF TEMPERATURE SENSING FOLEY CATHETER FAILED TO DEFLATE AFTER THE BALLOON CHECKED PRIOR TO INSERTION. WE HAVE TWO SEPARATE SAMPLES SEQUESTERED PENDING RECEIPT OF RETURN KITS: 1. YNHHS TRACKER # 3396 ¿ BD PRODUCT #A942206 TRAY CATHETER URINE FOLEY SURESTEP 6FR ¿ COMPLAINT SUBMITTED NOV 6, 2023. 2. YNHHS TRACKER # 3403 ¿ BD PRODUCT #A319516AM TRAY FOLEY URINE METER TEMP SENSING 16FR X 5CC ¿ COMPLAINT SUBMITTED NOV 6, 2023. PER FOLLOW UP VIA EMAIL ON 15DEC2023, IT WAS REPORTED THAT THE SAMPLE WAS SENT BACK FOR EVALUATION ON 13DEC2023. THE PRODUCT ISSUE WAS OBSERVED PRIOR TO INSERTION AND THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282256 ↗
• MalfunctionNov 27, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE CUSTOMER WAS CONCERNING AN EVENT WHILE USING A BARD PRODUCT FOLEY TRAY. THE LOT NUMBER WAS UNKNOWN. NO HARM TO THE PATIENT HAD BEEN REPORTED. THE EVENT DATE WAS 25OCT2023. THEY HAD ONE EACH OF THE DEFECTIVE SAMPLE AVAILABLE TO RETURN FOR ANALYSIS. THE CLINICIANS DESCRIBE THE COMPLAINT, FOLEY CATHETER IN PATIENT, WHILE CARING FOR PATIENT FOLEY HAD COME OUT AND NOTED THAT THE BALLOON WAS POPPED/NOT INTACT. NEW FOLEY CATHETER HAD TO BE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208698 ↗