SureStep™ Foley Tray System Complete Care® Add-A-Foley Catheter A304400ARecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741073847), received between Oct 4, 2017 and Jan 16, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Component Missing” (6 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-3118-2026 · Root cause: Under Investigation by firm · 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.

• MalfunctionJan 16, 2026Fungus in Device Environment

  IT WAS REPORTED THAT CUSTOMER FOUND BLACK MOLD GROWING IN THE PREP PACKET OF THE FOLEY. THIS WAS THE SECOND INSTANCE THIS HAD HAPPENED IN THE OR. PRODUCT WAS DISCARDED AND NEW PRODUCT OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24093579 ↗
• MalfunctionJan 16, 2026Fungus in Device Environment

  IT WAS REPORTED THAT CUSTOMER FOUND BLACK MOLD GROWING IN THE PREP PACKET OF THE FOLEY. THIS WAS THE SECOND INSTANCE THIS HAD HAPPENED IN THE OR. PRODUCT WAS DISCARDED AND NEW PRODUCT OPENED. (DOE 05JAN2026) AND (DOE UNK).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24093571 ↗
• MalfunctionNov 26, 2025Fungus in Device Environment; Fungus in Device Environment

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED ANOTHER COMPLAINT FOR A304400A. MOLD WAS FOUND IN THE CLINICLEAN CASTILE SOAP TOILETTES THAT CAME INDIVIDUALLY PACKED IN THE SURESTEP FOLEY TRAY SYSTEM WITHOUT A FOLEY CATHETER. REF# A304400A, LOT# NGKU3043, EXP 07-31-2026, TOILETTE LOT10) MK05525. IT WAS DISCARDED AND NEVER USED ON THE PATIENT. NO EXPIRATION DATE WAS AVAILABLE ON THE CLINICLEAN PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658436 ↗
• MalfunctionFeb 10, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THREE OF THE INDWELLING URINARY CATHETERS BEING WASTED DUE TO MISSING PROXIMAL PORTS AND THIS WAS HAPPENED OVER THE WEEKEND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16352056 ↗
• MalfunctionJun 17, 2020Component Missing

  IT WAS REPORTED THAT THE SURE STEP FOLEY TRAY DID NOT HAVE THE 10 CC SYRINGE FILLED WITH STERILE WATER, SO THEY WERE NOT EFFICIENT.

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

  MAUDE report 10164806 ↗
• MalfunctionMar 25, 2020Component Missing

  IT WAS REPORTED THAT THE KITS WERE MISSING THE LUBRICANT AND SYRINGES.

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

  MAUDE report 9877858 ↗
• MalfunctionMar 25, 2020Misassembled; Component Missing; Misassembled

  IT WAS REPORTED THAT THE KITS WERE MISSING THE LUBRICANT AND SYRINGES.

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

  MAUDE report 9877717 ↗
• MalfunctionDec 19, 2019Component Missing

  IT WAS REPORTED THAT THE FOLEY TRAY WAS MISSING THE FOAM SWABS.

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

  MAUDE report 9497334 ↗
• MalfunctionMay 22, 2019Component Missing

  IT WAS REPORTED THAT THE SURESTEP FOLEY TRAY WAS MISSING THE IODINE SWABSTICKS. THE YELLOW STICKER THAT SHOULD HAVE INDICATED THAT THE SWABS WERE MISSING WAS NOT PRESENT ON THE PACKAGING.

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

  MAUDE report 8630661 ↗
• MalfunctionFeb 5, 2019Deformation Due to Compressive Stress; Improper Flow or Infusion; Material Deformation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THERE WAS A KINK IN THE TUBING OF THE DRAIN BAG THAT PREVENTED THE FLOW OF URINE.

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

  MAUDE report 8304863 ↗
• MalfunctionFeb 5, 2019Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THERE WAS A KINK IN THE TUBING OF THE DRAIN BAG THAT PREVENTED THE FLOW OF URINE.

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

  MAUDE report 8304710 ↗
• MalfunctionOct 4, 2017Component Missing

  IT WAS REPORTED THAT THE KIT CONTAINED NO INFLATION SYRINGE. THE COMPLAINANT ALLEGED ANOTHER SYRINGE WAS GRABBED AND FILLED WITH WATER FOR INSERTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6913706 ↗