SureStep™ Foley Tray System with Bard® Lubri-Sil® Temp Sensing Foley Catheter A119214MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741073670), received between Dec 7, 2018 and May 13, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Infuse” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2020Material Protrusion/Extrusion; Material Erosion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE CORD ON THE TEMPERATURE SENSOR HAD ERODED THROUGH THE SHAFT OF THE FOLEY, NEAR THE 3-WAY PORT. IT WAS NOTICED WHEN THE NURSE WAS ASSESSING THE PATIENT. IT WAS IMMEDIATELY REMOVED AND THERE WAS NO HARM WAS DONE TO THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 10051316 ↗
• MalfunctionDec 7, 2018Failure to Infuse; Material Puncture/Hole; Failure to Infuse

  IT WAS REPORTED THAT WHEN INFLATING THE FOLEY BALLOON THERE WERE SMALL HOLES IN THE SHAFT ABOUT 1 INCH BELOW THE BALLOON THAT CAUSED THE STERILE WATER TO SPRAY OUT. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8141352 ↗