Bard® Foley Catheter Silicone Coated 265724Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741039638), received between Jul 24, 2017 and Sep 11, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Deflation 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.

• MalfunctionSep 11, 2020Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAK AROUND THE FOLEY CATHETER.

  Patient problems: Insufficient Information; No Consequences Or Impact To Patient

  MAUDE report 10521385 ↗
• MalfunctionMay 1, 2019Deflation Problem; Device Dislodged or Dislocated; Deflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER CAME OUT OF THE CUSTOMER'S ABDOMEN DURING THE NIGHT. THE CUSTOMER ALLEGED THE HOSPITAL INSERTED A SECOND FOLEY THAT SHE BROUGHT WITH HER.

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

  MAUDE report 8567959 ↗
• MalfunctionJul 24, 2017Inflation Problem

  IT WAS REPORTED THAT AFTER ATTEMPTING TO INJECT 10CC OF WATER, THE CATHETER BALLOON WOULD NOT COMPLETELY INFLATE.

  Patient problems: No Information

  MAUDE report 6739163 ↗