Bardex® Lubri-Sil® All-Silicone Foley Catheter 70518LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741034350), received between Sep 5, 2023 and Mar 2, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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.

• MalfunctionMar 2, 2026Inability to Irrigate

  IT WAS REPORTED BY THE CUSTOMER THAT THEIR STAFF HAD EXPERIENCED ISSUES WITH SOME REF# 70518L FOLEY CATHETERS, INCLUDING HOLES NEAR THE CONNECTORS ON CERTAIN UNITS AND INABILITY TO FLUSH FLUID THROUGH OTHERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491521 ↗
• MalfunctionMar 2, 2026Fracture; Material Split, Cut or Torn

  IT WAS REPORTED BY THE CUSTOMER THAT THEIR STAFF HAD EXPERIENCED ISSUES WITH SOME REF 70518L FOLEY CATHETERS, INCLUDING HOLES NEAR THE CONNECTORS ON CERTAIN UNITS AND INABILITY TO FLUSH FLUID THROUGH OTHERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491520 ↗
• MalfunctionFeb 27, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT ONE OF THE NURSES SAID THAT THE FOLEY CATHETERS HAD HOLES IN THE CONNECTOR AND THAT WAS LEAKED, THEY NOTICED THAT ON 3 OF THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24475126 ↗
• MalfunctionAug 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A THREE-WAY FOLEY CATHETER WAS PLACED IN PATIENT UPON PLACEMENT OF THE CATHETER AND IT WAS NOTICED TO BE LEAKING URINE NEAR 3 WAY HUB. CATHETER WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816306 ↗
• MalfunctionSep 5, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A PINHOLE LEAK WAS NOTED UPON INSERTION AT THEY AREA OF THE FOLEY CATHETER AND IT WAS CURRENTLY MARKED WITH A TAPE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17682704 ↗