SureStep™ Foley Tray System Lubri-Sil® IC Complete Care® A303414ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741073816), received between May 25, 2017 and Jan 30, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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-3116-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Material Fragmentation

  IT WAS REPORTED THAT AS PER THE CUSTOMER THEY JUST WANTED TO REPORT THE ISSUE TO THEIR COMPANY TO SEE IF THAT HAD BEEN AN ONGOING ISSUE FOR CLIENTS OF THAT DEVICE. THE REPORT TO THEM WAS THAT THE NURSE INSERTED THE FOLEY CATHETER, WAS INFLATING THE BALLOON THAT HOLDS THE WATER. WHILE DISCONNECTING THE SYRINGE THE LUER TIP BROKE OFF INSIDE THE BALLOON PORT AND WAS JAGGED. THAT MADE THE NURSE HAD TO REMOVE THE DEVICE DUE TO POSSIBLE PATIENT INJURY AND INFECTION ROUTE. THE PATIENT HAD ANOTHER SYSTEM PLACED WITHOUT DEVICE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223871 ↗
• MalfunctionJul 10, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT DURING INSERTION ASSESSMENT TRAY WAS USED AND FOUND TO NOT HAVE SWABS IN THE TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468735 ↗
• MalfunctionApr 22, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT CUSTOMER FOUND FOLEY TRAY THAT HAD TWO DIFFERENT REFERENCE NUMBERS ON THE PACKAGE. ONE SIDE SAID A303314A AND THE OTHER SAID A303414A, WHICH WAS A MATTER OF LATEX VS LATEX FREE, SO THEY COULD NOT USE THE ITEMS IF THEY WERE NOT CERTAIN WHAT THEY WERE. PROBLEM WAS NOTICED PRIOR TO USE. NO MEDICAL TREATMENT WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882184 ↗
• MalfunctionAug 20, 2020Component Missing

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS MISSING THE TRAY.

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

  MAUDE report 10430999 ↗
• MalfunctionFeb 15, 2019Fluid/Blood Leak; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CATHETERS LEAKED. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 8342912 ↗
• MalfunctionMay 25, 2017Unsealed Device Packaging

  IT WAS REPORTED THAT THE SEAL WAS BROKEN ON THE PACKAGING OF THE TRAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6592990 ↗