Bardex® Lubri-Sil® I.C. All-Silicone Temp Sensing Foley Catheter 119318MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741039928), received between Sep 23, 2021 and Nov 27, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Dent in Material” (1 report).

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

• InjuryNov 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE PATIENT EXPERIENCED AND ADVERSE EVENT DIRECTLY CAUSED AND ATTRIBUTABLE TO THE USAGE OF THE DEVICE TEMPERATURE SENSING FOLEY CATHETER AND THE RESULTED IN THE FOLLOWING COMPLICATIONS WAS LEAKAGE. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON (B)(6)2024, STATED THAT THE RESPONDENT INDICATED THE PATIENT DID REQUIRED MEDICAL OR SURGICAL INTERVENTION AND INDICATED SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20796730 ↗
• MalfunctionSep 23, 2021Dent in Material; Dent in Material

  IT WAS REPORTED THAT TEMPERATURE SENSING FOLEY CATHETER HAD LEAKED AROUND THE INSERTION SITE OVERNIGHT, WETTING THE BED. THE CUSTOMER REMOVED THE CATHETER AND INFLATED THE BALLOON. THE BALLOON ONLY INFLATED ON ONE SIDE LEAVING THE OTHER SIDE OF THE BALLOON FLUSH AGAINST THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12519269 ↗