SureStep™ Foley Tray System Bard® Lubricath Foley A800365Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741073960), received between May 19, 2017 and Aug 23, 2024 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Component Missing” (5 reports).

2 FDA recall records name this device's identifier, 2 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-3114-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Aug 5, 2021Class IIOpen, Classified

   There is potential for packaging defects that may impact the sterile barrier.

   Z-2532-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT PATIENT WAS UNABLE TO VOID POST-OP, PHYSICIAN ORDERED FOLEY CATHETER INSERTION. NURSE OPENED ONE FOLEY CATHETER KIT AND CATHETER WAS MISSING (MW5157012). NO EXTRA FOLEY CATHETER WAS AVAILABLE IN DEPARTMENT, SO ANOTHER KIT WAS OPENED. NURSES DISCOVERED THE COVERING OF THE CATHETER WAS TORN OPENED (MW5157013). NURSES DECIDED TO OPEN A THIRD KIT AND AGAIN THE COVERING OVER THE CATHETER WAS TORN (MW5157011). HOUSE SUPERVISOR WAS NOTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20047998 ↗
• MalfunctionJan 19, 2024Short Fill; Short Fill

  IT WAS REPORTED THAT FOLEY CATHETER KIT DID NOT HAVE ADEQUATE SALINE IN PREFILLED SYRINGE FOR RETENTION BULB. CATHETER KIT ALSO DID NOT HAVE ORANGE STICKERS FOR CHART OR CATHETER TIME OR DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18542424 ↗
• MalfunctionJan 18, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT FOLEY CATHETER KIT DID NOT HAVE ADEQUATE SALINE IN PREFILLED SYRINGE FOR RETENTION BULB. CATHETER KIT ALSO DID NOT HAVE ORANGE STICKERS FOR CHART OR CATHETER TIME OR DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18533993 ↗
• MalfunctionAug 26, 2022Component Missing; Component Misassembled; Component Missing; Component Misassembled

  IT WAS REPORTED THAT WHEN THE SURESTEP FOLEY KIT WAS OPENED, THE 10 ML FLUSH SYRINGE INSIDE THE KIT HAD NO FLUID OR END CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15302682 ↗
• MalfunctionJul 11, 2022Short Fill; Short Fill

  IT WAS REPORTED THAT THE NURSE OPENED A 16F BARD FOLEY SURE-STEP TRAY SYSTEM AND FOUND THAT THE PREFILLED SYRINGE PARTIALLY EMPTY AND MISSING THE CAP .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14978557 ↗
• MalfunctionJul 8, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE NURSE OPENED A 16F BARD FOLEY SURE-STEP TRAY SYSTEM AND FOUND THAT THE PREFILLED SYRINGE PARTIALLY EMPTY AND MISSING THE CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14962245 ↗
• MalfunctionDec 14, 2021Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ALLERGIC REACTIONS WITH THE USE OF LATEX URINARY CATHETERS. IT WAS STATED THAT THE PATIENT REQUIRED SURGICAL AIRWAY DUE TO ALLERGIC REACTIONS. THE CUSTOMER REPORTED THAT UPON REVIEWING THEIR CURRENT MATERIALS, IT WAS APPARENT THAT THE LABELLING OF FOLEY KITS AND THE INDIVIDUAL CATHETERS, WITH RESPECT TO LATEX-STATUS HAD NOT BEEN AS EFFECTIVE AS THEY WISHED. IT WAS STATED THAT THE LATEX CAUTION LABEL WAS NOT EASILY VISIBLE, AND IT COULD BE DIFFICULT TO TELL THE DIFFERENCE BETWEEN LATEX AND LATEX-FREE KITS. ALSO STATED THAT THE INDIVIDUAL URINARY CATHETERS MIGHT ALSO CONTAIN LATEX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13004283 ↗
• MalfunctionSep 30, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE SURESTEP FOLEY TRAY SYSTEM HAD ONLY 2 BETADINE SWABS WERE PRESENT INSTEAD OF 3 SWABS. THE CUSTOMER ALSO REPORTED THAT ONE SWAB WAS TURNED TO FACE THE WRONG WAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12555762 ↗
• MalfunctionMar 5, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE FOLEY TRAY DID NOT HAVE A STATLOCK SECUREMENT DEVICE AS IT WAS SUPPOSED TO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11423466 ↗
• MalfunctionFeb 5, 2020Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE GREEN TUBE WOULD NOT DRAIN PROPERLY. PER FOLLOW UP ON 20JAN2020, THE TUBING WAS BENT AND GLUED TO THE DRAIN BAG AND WAS NOT ABLE TO BE DRAIN.

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

  MAUDE report 9671916 ↗
• InjuryDec 27, 2018Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT FIVE DIFFERENT PATIENTS EXPERIENCED A LEAK WITH THE VENT PORT ON THE FOLEY CATHETER. THE FIVE PATIENTS WERE ALLEGEDLY DIAGNOSED WITH CAUTI'S (CATHETER ASSOCIATED URINARY TRACT INFECTIONS). IT IS UNKNOWN AT THIS TIME OF THE MEDICAL INTERVENTIONS NEEDED.

  Patient problems: Unspecified Infection; Urinary Tract Infection

  MAUDE report 8199931 ↗
• MalfunctionMay 19, 2017Misassembled

  IT WAS REPORTED THAT THE GLOVES IN THE TRAY WERE CRUMPLED AND COULD NOT BE PUT ON ASCEPTICALLY.

  Patient problems: No Patient Involvement

  MAUDE report 6578618 ↗