SureStep™ Foley Tray System Lubri-Sil® IC Complete Care® A303418ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741073830), received between May 14, 2018 and Sep 26, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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-3115-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2022Material Too Rigid or Stiff

  UPON REMOVAL OF FOLEY, IT WAS NOTED TO HAVE A HARD RIDGE TO WHICH THE PATIENT WAS COMPLAINING OF PAIN DURING REMOVAL.

  Patient problems: Pain

  MAUDE report 15484849 ↗
• MalfunctionMay 15, 2018Burst Container or Vessel

  IT WAS REPORTED THAT THE CATHETER BALLOON BURST AFTER THE DOCTOR INFLATED THE BALLOON AND DISCONNECTED THE SYRINGE. THE COMPLAINANT REPORTED THAT AS A RESULT OF THIS, THE CATHETER FELL OUT OF THE PATIENT AND WAS REPLACED WITH "A WIRE GUIDED FOLEY AND WAS PLACED WITHOUT ANY PROBLEMS". PER ADDITIONAL INFORMATION RECEIVED, THE BALLOON WAS FILLED WITH 10 CC OF FLUID AND NO PIECES OF THE CATHETER BALLOON WERE MISSING. THE PATIENT REPORTEDLY EXPERIENCED DISCOMFORT WITH INSERTION OF THE CATHETER.

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

  MAUDE report 7515654 ↗
• MalfunctionMay 14, 2018Burst Container or Vessel; Component Falling

  IT WAS REPORTED THAT THE CATHETER BALLOON BURST AFTER THE DOCTOR INFLATED THE BALLOON AND DISCONNECTED THE SYRINGE. COMPLAINANT REPORTED THAT AS A RESULT, THE CATHETER FELL OUT OF THE PATIENT AND WAS REPLACED. IT WAS LATER REPORTED THAT THE BALLOON WAS FILLED WITH 10 CC OF FLUID AND NO PIECES OF THE CATHETER BALLOON WERE MISSING. ALLEGEDLY, THE PATIENT EXPERIENCED DISCOMFORT WITH INSERTION OF THE CATHETER.

  Patient problems: Discomfort

  MAUDE report 7512292 ↗