SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter A907316Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741104749), received between Nov 9, 2023 and Mar 25, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2024Restricted Flow rate; Physical Resistance/Sticking; Restricted Flow rate; Physical Resistance/Sticking

  IT WAS REPORTED THAT THEY HAD ATLEAST 5 INCIDENTS WHERE A BARD LATEX FREE FOLEY CATHETER COLLECTION BAG WAS FUSED TOGETHER AT THE DRAINAGE SECTION. THE URINE COULD NOT BE EMPTIED BY THE NURSE. TWO LOT # APPEARED TO BE AFFECTED. (LOT #NGHU3116), (LOT #NGHT3405). PER CUSTOMER FOLLOW UP RECEIVED ON 28MAR2024, AFFECTED CATHETERS WERE DISCARDED. HOWEVER, THEY HAVE REQUESTED 24 CASES OF THE 16FR CATHETERS WITH THE TWO LOT'S REPORTED AS HAVING FUSED BAGS. THE AFFECTED CATHETER WAS REPLACED. THE BAG APPEARED TO BE FUSED AT THE JUNCTION OF THE TUBE AND COLLECTION BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967941 ↗
• MalfunctionMar 25, 2024Restricted Flow rate; Physical Resistance/Sticking; Restricted Flow rate; Physical Resistance/Sticking

  IT WAS REPORTED THAT THEY HAD ATLEAST 5 INCIDENTS WHERE A BARD LATEX FREE FOLEY CATHETER COLLECTION BAG WAS FUSED TOGETHER AT THE DRAINAGE SECTION. THE URINE COULD NOT BE EMPTIED BY THE NURSE. TWO LOT # APPEARED TO BE AFFECTED. (LOT #NGHU3116), (LOT #NGHT3405). PER CUSTOMER FOLLOW UP RECEIVED ON 28MAR2024, AFFECTED CATHETERS WERE DISCARDED. HOWEVER, THEY HAVE REQUESTED 24 CASES OF THE 16FR CATHETERS WITH THE TWO LOT# REPORTED AS HAVING FUSED BAGS. THE AFFECTED CATHETER WAS REPLACED. THE BAG APPEARED TO BE FUSED AT THE JUNCTION OF THE TUBE AND COLLECTION BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967937 ↗
• MalfunctionNov 9, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THERE WAS NO CATHETER PRESENT IN THE CATHETER KIT. IT ALSO APPEARED AS IF THE CATHETER BAG TUBING WAS CUT SHORT AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18100126 ↗