Bard® Foley Tray with Hydrophilic-Coated Foley Catheter 861016Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741040399), received between Aug 13, 2019 and Aug 13, 2019 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2019Deflation Problem

  IT WAS REPORTED THAT THE SILICONE FOLEY BALLOON WOULD NOT DEFLATE AFTER BEING PLACED FOR APPROXIMATELY TWO HOURS. THE NURSE WAS INITIALLY ABLE TO REMOVE APPROXIMATELY 7ML FROM THE BALLOON INJECTION PORT BUT RESISTANCE REMAINED AT THAT TIME. THE UROLOGIST WAS CALLED IN AND ATTEMPTED TO DEFLATE THE BALLOON FURTHER WITH PROBES THROUGH THE INJECTION CHANNELS AND WAS UNSUCCESSFUL. THE CATHETER WAS CUT IN ADDITION TO A STYLET BEING USED TO PUNCTURE THE BALLOON.

  Patient problems: No Known Impact Or Consequence To Patient; Patient Problem/Medical Problem

  MAUDE report 8888203 ↗