Bardex® Lubricath® Foley Catheter 0166L12Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741017568), received between Dec 13, 2024 and Jun 25, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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.

• InjuryJun 25, 2026Material Rupture

  IT WAS REPORTED THAT WHILE IN PLACE THE FOLEY CATHETER BALLOON POPPED ON (B)(6) 2026 AND CUSTOMER HAD TO UNDERGO A PROCEDURE TO REMOVE BALLOON FRAGMENTS AND TAKE A COURSE OF ANTIBIOTICS. PRODUCT CODE D226612, PRODUCT NAME BIO HYDROGEL MALE SIZE 12 1'S, LOT NUMBER MYKV2476, NUMBER OF EFFECTED PRODUCTS. 1.

  Patient problems: Foreign Body In Patient

  MAUDE report 25625633 ↗
• MalfunctionDec 13, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A FEW HOURS AFTER IMPLANTATION, THEY STARTED USING THE FOLEY CATHETER DURING SURGERY, AND WHEN THEY CHECKED AFTER THE SURGERY, THE STERILE WATER HAD LEAKED AND DRAINED OUT. AFTER IT WAS DRAINED, THE WATER WAS INJECTED AGAIN, BUT IT COULD NOT BE REPRODUCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924596 ↗