SureStep™ Foley Tray Lubri-Sil® I.C. Complete Care® Temp Sensing Catheter A300916ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741120862), received between Feb 28, 2018 and Oct 29, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (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.

• MalfunctionOct 29, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE TEMPERATURE SENSING FOLEY CATHETER WAS SHOWING INTERMITTENT TEMPERATURE READINGS ON THE MONITOR DUE TO CONNECTION OF THE MONO JACK (NGFV2481 (B)(6)). THE PHILIPS TEMPERATURE CABLE USED TO CONNECT TO THE HEMODYNAMIC MONITOR. THE TEMPERATURE READING WOULD LITERALLY BE THERE ONE MOMENT THEN DISAPPEARED AND DID NOT ALWAYS COME BACK EVEN THOUGH THE EXTENSION CABLE WAS CONNECTED. THE ISSUE OCCURRED MULTIPLE TIMES AND IT WAS APPEARED TO BE WITH THE EXTENSION CABLES. AFTER REPLACING THE BLACK CABLE THAT COMES WITH THE KIT WITH THE BLUE CABLES WHICH HAD PURCHASED SECOND HAND SEEMED TO SOLVE THE ISSUE. THE USER HAD ALSO NOTICED THE TEMPERATURE READING DISPLAYED WOULD OR COULD DROP SIGNIFICANTLY. IN SOME CASES, THE TEMPERATURE MOVES UP TO 10 DEGREE C OR MORE WHICH ALSO DID NOT ALWAYS CORRECT ITSELF. AFTER FURTHER TROUBLESHOOTING, FOUND THAT THE RETENTION OF THE MONO JACK TO THE KIT CABLE WAS VERY WEAK AND COULD BE CAUSING DISCONNECTION VERY EASILY DURING PROCEDURES. THE USER ALSO NOTICED THAT THE KIT CABLES WERE NOT VERY ACCURATE. THE USER USED A RESISTOR TEST TRANSDUCER THAT SIMULATED 36.0C AND ALL THE BLUE CABLES USED IN LINE WITH A PHILIPS TEMPERATURE CABLE WERE EX

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12721389 ↗
• MalfunctionOct 26, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE TEMPERATURE SENSING FOLEY CATHETER WAS SHOWING INTERMITTENT TEMPERATURE READINGS ON THE MONITOR DUE TO CONNECTION OF THE MONO JACK. THE PHILIPS TEMPERATURE CABLE USED TO CONNECT TO THE HEMODYNAMIC MONITOR. THE TEMPERATURE READING WOULD LITERALLY BE THERE ONE MOMENT THEN DISAPPEARED, DID NOT ALWAYS COME BACK EVEN THOUGH THE EXTENSION CABLE WAS CONNECTED. THE ISSUE OCCURRED MULTIPLE TIMES, AND IT APPEARED TO BE WITH THE EXTENSION CABLES. AFTER REPLACING THE BLACK CABLE THAT COMES WITH THE KIT WITH THE BLUE CABLES WHICH WAS PURCHASED SECOND HAND SEEMED TO SOLVE THE ISSUE. THE USER HAD ALSO NOTICED THE TEMPERATURE READING DISPLAYED WOULD OR COULD DROP SIGNIFICANTLY. IN SOME CASES, THE TEMPERATURE MOVES UP TO 10C OR MORE, WHICH ALSO DID NOT ALWAYS CORRECT ITSELF. AFTER FURTHER TROUBLESHOOTING, FOUND THAT THE RETENTION OF THE MONO JACK TO THE KIT CABLE WAS VERY WEAK AND COULD BE CAUSING DISCONNECTION VERY EASILY DURING PROCEDURES. THE USER ALSO NOTICED THAT THE KIT CABLES WERE NOT VERY ACCURATE. THE USER USED A RESISTOR TEST TRANSDUCER THAT SIMULATED 36.0C AND ALL THE BLUE CABLES USED IN LINE WITH A PHILIPS TEMPERATURE CABLE WERE EXACTLY AT 36.0C, BUT THE KIT CAB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698003 ↗
• MalfunctionFeb 28, 2018Component Missing

  IT WAS REPORTED THAT THE CABLE WAS MISSING FROM THE KIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7303455 ↗