Bardex® I.C. Foley Catheter 0165SI30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741016820), received between Mar 18, 2020 and Jun 23, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (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.

• MalfunctionJun 23, 2020Decrease in Pressure; Deflation Problem; Decrease in Pressure; Device Slipped

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON DEFLATED PREMATURELY AND FELL OUT OF THE PATIENT. IT WAS NOTED THAT THE BALLOON WAS INFLATED WITH 10CC STERILE WATER.

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

  MAUDE report 10183548 ↗
• MalfunctionMar 18, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER LEAKS WHEN THERE IS HEAVY URINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9850310 ↗