Bardex® Lubri-Sil® All-Silicone Temp Sensing Foley Catheter 119208MRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741046261), received between Mar 19, 2020 and Oct 21, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (4 reports).

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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2020Inaccurate Flow Rate; Component Misassembled; Inaccurate Flow Rate; Component Misassembled

  IT WAS REPORTED THAT TEMPERATURE-SENSING CATHETER WERE DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10714836 ↗
• MalfunctionOct 21, 2020Inaccurate Flow Rate; Component Misassembled; Inaccurate Flow Rate; Component Misassembled

  IT WAS REPORTED THAT THE TEMPERATURE-SENSING CATHETER WAS NOT FLUSHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10709534 ↗
• MalfunctionOct 21, 2020Inaccurate Flow Rate; Component Misassembled; Inaccurate Flow Rate; Component Misassembled

  IT WAS REPORTED THAT TEMPERATURE-SENSING CATHETER WERE DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10709533 ↗
• MalfunctionOct 2, 2020Component Misassembled; Device Sensing Problem; Component Misassembled

  IT WAS REPORTED THAT TEMPERATURE-SENSING CATHETER WERE DEFECTIVE. AS PER THE FOLLOW UP VIA EMAIL ON 11SEP2020, ACCORDING TO THE REPORT, TWO CATHETERS WERE USED ON THE PATIENT. NO NEGATIVE IMPACT NOTED OTHER THAN MULTIPLE UNNECESSARY CATHETERIZATIONS. THE EXACT DEFECT IN THE CATHETER WAS NOT FLUSHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10623149 ↗
• MalfunctionMar 19, 2020Misassembled; Defective Device; Misassembled

  IT WAS REPORTED THAT THE 8 FR TEMP-SENSING FOLEY WAS FOUND TO BE NOT PATENT AFTER ATTEMPTED INSERTION IN A PATIENT. PER ADDITIONAL INFORMATION RECEIVED, THE FOLEY DID NOT DRAIN. WHEN THE UROLOGIST CAME TO ASSIST, HE EXAMINED THE FOLEY AFTER THE REMOVAL AND THERE WAS NO HOLE IN THE END OF THE FOLEY FOR THE URINE TO DRAIN OUT.

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

  MAUDE report 9856402 ↗