Bardex® Lubricath® Foley Catheter 0166L30Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741017650), received between Nov 26, 2019 and Oct 30, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT FOLEY BALLOON PLACED AND FILLED WITH 60 ML SALINE FOR CERVICAL RIPENING. FIRST CHECK UNREMARKABLE WITH BALLOON TUGGED WITH GENTLE PRESSURE, SECOND CHECK WITH GENTLE PRESSURE FOLEY CATHETER BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23427655 ↗
• MalfunctionDec 2, 2019Inflation Problem; Material Twisted/Bent

  IT WAS REPORTED THAT THE DISTRIBUTOR UNPACKAGED EACH DEVICE FROM THE BD BOX AND FOLDED THEM TO FIT INTO A SMALLER BOX FOR THE CUSTOMER SINCE SHE DID NOT ORDER A FULL CASE. THE CUSTOMER REPORTED THAT WHEN SHE RECEIVED THE CATHETERS, THEY WERE BENT WHERE THE BALLOON IS LOCATED SO WHEN SHE ATTEMPTED TO INFLATE THE BALLOON IT ONLY INFLATED ON 1 SIDE.

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

  MAUDE report 9394845 ↗
• MalfunctionNov 26, 2019Use of Device Problem; Leak/Splash; Use of Device Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER LEAKED AROUND THE MEATUS WHERE IT WAS INSERTED INTO THE STOMACH.

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

  MAUDE report 9374996 ↗