SureStep™ Foley Tray System with Bardex® Lubricath Temp Sensing Foley Catheter A119416MRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741073700), received between Jun 12, 2018 and Mar 17, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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-3114-2026 · 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.

• MalfunctionMar 17, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THEY OPENED TRAY AND HAIR WAS FOUND WITHIN THE STERILE PACKAGING. AND DID NOT REACH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621746 ↗
• MalfunctionJul 3, 2025Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE ORIGIN OF THE ISSUE WAS SURGERY. IT WAS NOTED THAT THE GIVEN LOT# WAS NGKQ2923.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396904 ↗
• MalfunctionNov 14, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A PIECE OF ZIP TIE FOUND INSIDE 10ML STERILE WATER SYRINGE THAT CAME IN FOLEY TRAY KIT. SYRINGE WAS REMOVED AND REPLACED WITH NEW WATER SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18130314 ↗
• MalfunctionDec 16, 2022Melted; Melted

  IT WAS REPORTED THAT WHEN THE FOLEY TRAY WAS OPENED THERE WAS A CERTAIN SMELL OF "MELTED PLASTIC". IT WAS STATED THAT ONE OF THE FOLEY WAS MELTED TO THE TRAY. IT WAS ALSO REPORTED THAT THE ISSUE HAPPENED WITH TWO TRAYS FROM THE SAME LOT# AND WHEN THE THIRD TRAY WAS OPENED FROM A DIFFERENT LOT, THERE WAS NO ISSUE. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 13DEC2022, IT WAS REPORTED THAT THE MELTED FOLEY WAS STUCK TO THE TRAY SO IT WAS NOT USED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996343 ↗
• MalfunctionAug 31, 2021Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT TEMPERATURE SENSING FOLEY CATHETER WAS READING TOO HIGH. WHEN THE ESOPHAGEAL PROBE WAS PLACED, FOLEY REMAINED HIGH WHEN COMPARED TO ESOPHAGEAL. CALIBRATION OF THE PHILIPS MONITOR WAS CHECKED BY THEIR BIOMED AND FOUND TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12401602 ↗
• MalfunctionMar 26, 2019Fluid/Blood Leak; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE TEMPERATURE SENSING CATHETER WAS LEAKING.

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

  MAUDE report 8451174 ↗
• MalfunctionJun 12, 2018Erratic or Intermittent Display; Incorrect, Inadequate or Imprecise Result or Readings; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE TEMPERATURE SENSING CATHETER READ 32 DEGREES, WHICH DID NOT MATCH THE READINGS OF OTHER DEVICES USED ON THE PATIENT FOR TEMPERATURE READINGS.

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

  MAUDE report 7591171 ↗