SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter A947314Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741074134), received between Jan 30, 2024 and Nov 10, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (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-3115-2026 · Root cause: Under Investigation by firm · 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.

• MalfunctionNov 10, 2025Component Missing; Component Misassembled; Component Missing; Component Misassembled

  IT WAS REPORTED THAT THE FOLEY KIT ONLY CONTAINED ONE STERILE BETADINE SWAP INSTEAD OF THREE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512476 ↗
• InjuryMay 8, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT FIRST FOLEY CATHETER BALLOON WOULD NOT DEFLATE (LOT#NGGT3607, LOT#NGHW2288). THERE WERE TWO NURSES WHO ATTEMPTED BUT ONLY WAS ABLE TO REMOVE 3 TO 4 ML OF FLUID AND STILL HAD RESISTANCE. MD CUT THE VALVE END OFF OF THE FOLEY WITHOUT ANY ADDITIONAL FLUID. THE PATIENT HAD SEEN BY UROLOGY AND HAD TO GO TO SURGERY FOR REMOVAL. THERE WAS NO EVIDENCE OF STRUCTURE ISSUES OR FOREIGN BODIES TO EXPLAIN THE INABILITY TO DEFLATE THE BALLOON. FOLEY WAS RETAINED AND THEY DID NOT HAVE THE PACKAGING FOR THE EXACT LOT NUMBER OF THE CATHETER INVOLVED. SECOND PATIENT HAD A FOLEY PLACED IN THE LABOR ROOM, WAS TAKEN TO THE OR AND AT SOME POINT, THE FOLEY CAME OUT. IT WAS UNCLEAR AT THIS TIME IF BY FORCE OR A PROBLEM WITH THE FOLEY. AGAIN, UROLOGY WAS CONSULTED AND WOULD NEED SURGERY TO LOOK FOR THE BALLOON PIECES. WHEN LOOKING AT THE FOLEY, THE END WHERE THE BALLOON WOULD HAVE BEEN MISSING. FOLEY WAS RETAINED AND THE PACKAGING WAS NOT RETAINED BUT THE CNS IDENTIFIED THE LOT NUMBER ON THE BALLOON PORT NGHZ3408 AND MANUFACTURING NUMBER 175814. THEY IDENTIFIED THE NUMBER MATCHES THE PRODUCT STOCKED ON THE SECOND FLOOR IN WOMEN'S AND CHILDREN, RE FA947314. THEY DID NOT HAVE ANOTHER LATE

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

  MAUDE report 19267286 ↗
• MalfunctionJan 30, 2024Gel Leak; Gel Leak

  IT WAS REPORTED THAT CASTILE SOAP TOWELETTES OF THE FOLEY TRAY WERE IN A SEALED PACKAGE BUT WERE COMPLETELY DRIED OUT UPON OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606640 ↗