SureStep™ Foley Tray System Lubri-Sil® IC Complete Care® A319514AMRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741073885), received between Jun 5, 2020 and Nov 7, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT THE KIT WAS MISSING THE ACTUAL 14FR FOLEY CATHETER. EVERY OTHER ITEM WAS IN THE FOLEY TRAY KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23494940 ↗
• MalfunctionJun 16, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT KIT CONTAINED TWO LUBRICANT SYRINGES INSTEAD OF A STERILE WATER SYRINGE AND A LUBRICANT SYRINGE. NURSE OPENED ANOTHER TRAY TO SEE IF THERE WAS ANOTHER AFFECTED ONE HOWEVER KIT WAS GOOD TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212222 ↗
• MalfunctionMay 8, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT PATIENT HAD A TEMPERATURE SENSING FOLEY CATHETER IN AND IT WAS NOTED THAT THERE WAS NO URINE OUTPUT FOR THE CURRENT HOUR COMPARED TO THE PREVIOUS HOUR. WHEN LOOKING AT THE 14FR BALLOON END, THE BALLOON WAS RUPTURED AND NOT INTACT, THIS PARTICULAR FOLEY WAS ONLY PLACED SEVERAL HOURS PRIOR IN THE SAME DAY. NEW 14FR BALLOON TEMPERATURE PROBE FOLEY INSERTED WITHOUT DIFFICULTY AND PATIENT DID NOT EXPERIENCE ANY FURTHER ISSUES. PER FOLLOW UP VIA EMAIL ON 04MAY2023, IT WAS REPORTED THAT THE MODEL# A319514AM AND LOT# NGGYR024, AS OF NOW, THIS WAS THE ONLY REPORT THEY HAVE RECEIVED THAT HAS HAD THIS ISSUE. STATED THAT THE PATIENT HAD NO INJURY AS A RESULT AND THE CATHETER WAS DISPOSED OF WHEN IT WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16886191 ↗
• MalfunctionMar 21, 2023Component Missing; Component Misassembled; Component Missing; Component Misassembled

  IT WAS REPORTED THAT THE FOLEY TRAY 14FR HAD NO FOLEY CATHETER ATTACHED TO DRAINAGE SYSTEM . PER FOLLOW UP VIA EMAIL RESPONSE ON (B)(6) 2023, IT WAS REPORTED THAT THE FOLEY CATHETER EXPELLED WITH FUDUS EVALUATION IN OPERATING ROOM 3 SPECIAL CASES. STATED THAT 14 FRENCH FOLEY REPLACED IN OPERATING ROOM DRAINING WELL 200CC INTIAL AND URINE OUTPUT IN CASE 150CC, INFLATION OF BALLOON WITNESSED AND DOCUMENTED ON 1ST INSERTION. THIS WAS A THEME THAT HAS BEEN REPORTED BEFORE OF FOLEYS BEING EXPELLED SPONTANEOUSLY. IN THIS CASE THE BALLOON WAS DEFLATED WHEN IT FELL OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582195 ↗
• MalfunctionSep 1, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE LUBRICANT SYRINGE WAS NOT CAPPED IN THE PACKAGE AND THE SYRINGE HAD SOME LUBRICANT IN IT BUT THE CONSISTENCY WAS LIKE PLASTIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12407656 ↗
• MalfunctionMay 19, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT FOAM SWABS APPARENTLY WERE NOT IN THE KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11848709 ↗
• MalfunctionJun 5, 2020Inadequate or Insufficient Training; Inadequate or Insufficient Training; Packaging Problem

  IT WAS REPORTED THAT THE CUSTOMER CLAIMED TO HAVE TWO DIFFERENT IFU¿S FOR THE TEMPERATURE SENSING FOLEY IN THE SAME PACKAGE.

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

  MAUDE report 10122197 ↗