SureStep™ Foley Tray System Lubri-Sil® IC Complete Care® A300416ARecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741073762), received between May 19, 2017 and Nov 4, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Component Missing” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025Fungus in Device Environment; Fungus in Device Environment

  IT WAS REPORTED THAT THEY FOUND SOME WIPES INSIDE A SURESTEP FOLEY KIT THAT APPEARED TO HAVE MOLD OR SOME SUBSTANCE ON THEM. THE WIPES WERE SAVED AND PRODUCT INFO INCLUDING LOT NUMBER IS BELOW. THE EVENT OCCURRED ON (B)(6) IN L&D. CUSTOMER IS THE POINT OF CONTACT FOR A RETURN BOX AND LABEL. MOLD FOUND ON ONE OF THE 3 SUPPLIED PERI WIPES. CUSTOMER RESPONDED VIA EMAIL ON (B)(6) 2025. IT WAS REPORTED THAT THE SAMPLE WAS SAVED AND IT IS IN UNIT MANAGER OFFICE. PENDING SAMPLE RETURN. LOT: (B)(4) WAS CONFIRMED AS THE AFFECTED LOT. THERE WAS NO HARM TO THE PATIENT. THE ISSUE WAS IDENTIFIED BEFORE USE ON THE PATIENT. IT WAS THE SECOND WIPE IN A PACK OF THREE, AND IT WAS THE WIPE DIRECTLY IN THE MIDDLE. NEITHER OF THE OTHER WIPES HAD ANY SIGNS OF MOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468651 ↗
• MalfunctionAug 28, 2025Defective Device; Defective Device

  IT WAS REPORTED THE END USER HAS STATED THERE WAS A MALFUNCTION WITH THIS ITEM AND WE HAVE QUARANTINED THE PRODUCT FOR YOUR EVALUATION. PRODUCT A300416A, LOT #NGKR2055. TRAY FOLEY IC BAG 16 FR SILICN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22911800 ↗
• MalfunctionNov 7, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT FOLEY TRAY WAS MISSING THE 10ML SALINE SYRINGE. NO PRODUCT WAS SAVED AS STAFF PULLED MISSING SYRINGE SEPARATELY AND USED THIS TRAY. PER SAMPLE RECEIVED ON (B)(6) 2023, IT WAS NOTED THAT THE BALLOON DILATION CATHETER WAS RETURNED FOR EVALUATION. PER SAMPLE RECEIVED ON (B)(6) 2023, IT WAS NOTED THAT THE EAGLE INFLATION DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18084539 ↗
• MalfunctionOct 21, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS FAILED TO FLOW AND FAILED TO DEFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12674197 ↗
• MalfunctionOct 21, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS FAILED TO FLOW AND FAILED TO DEFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12674079 ↗
• MalfunctionOct 22, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER'S FLUID WAS NOT REMOVED FROM THE BALLOON. IT WAS EVENTUALLY REMOVED WITH ABOUT 1 TO 2 ML OF FLUID IN IT. DURING AN ATTEMPT TO REMOVE THE FOLEY CATHETER FROM THE PATIENT, 10 ML OF AIR WAS REMOVED INSTEAD OF FLUID. ANOTHER ATTEMPT WAS MADE TO REMOVE THE FLUID, HOWEVER WITH SIGNIFICANT RESISTANCE, 3 ML OF NORMAL SALINE WAS REMOVED. THE PATIENT AND CATHETER WERE REPOSITIONED FOR ANOTHER ATTEMPT, WHICH LEAD TO THE CATHETER BEING REMOVED WITH 1-2 ML OF NORMAL SALINE LEFT IN THE BALLOON. AFTERWARDS, THE CATHETER WAS TESTED IN ORDER TO FILL BALLOON AND WITHDRAW THE FLUID. IT WAS DIFFICULT TO INSTILL, AND EVEN MORE FLUID REMAINED IN BALLOON WHEN ATTEMPTED TO WITHDRAW IT. THE TUBING WAS CUT AT THE 'Y' SITE, WHICH DID NOT ALLOW FLUID TO DRAIN OUT OF THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10718715 ↗
• MalfunctionMay 15, 2018Component Missing

  IT WAS REPORTED THAT 2 FOAM SWABS WERE MISSING FRO THE FOLEY TRAY.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 7514126 ↗
• MalfunctionMay 19, 2017Component Missing

  IT WAS REPORTED THAT UPON ATTEMPTING TO UTILIZE THE CATHETER TRAY, IT WAS NOTED THAT THE CATHETER WAS MISSING FROM THE TRAY. THERE WAS NO REPORTED PATIENT IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6578544 ↗
• MalfunctionMay 19, 2017Component Missing

  IT WAS REPORTED THAT, UPON OPENING THE TRAY, THE SWABSTICKS WERE MISSING. THE COMPLAINANT REPORTED THAT NEW SWABSTICKS WERE DROPPED INTO THE STERILE FIELD AND THE TRAY WAS STILL USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6578538 ↗