Bard® Urine Meter Foley Catheter Tray With Bardex® All-Silicone Catheter 902416Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741025068), received between Oct 2, 2019 and Oct 28, 2020 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2020Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING ISSUES WITH INFLATING AND DEFLATING THE BALLOON. FOLEY CATHETER BALLOON COULD NOT BE INFLATED WITH TYPICAL SYRINGE PRESSURE. BALLOON WAS NOT INFLATED, FOLEY REMOVED AND NEW PACKAGE OPENED. SECOND FOLEY INSERTED AND BALLOON INFLATED WITHOUT DIFFICULTY.

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

  MAUDE report 10751968 ↗
• MalfunctionOct 2, 2019Deflation Problem; Leak/Splash; Deflation Problem

  IT WAS REPORTED THAT THE HOSPITAL HAS BEEN NOTICING A LEAKING ISSUE A LOT MORE IN THE LAST 6-MONTHS TO A YEAR. MOST OF THE NEW KIDNEY TRANSPLANTS HAVE HAD THIS ISSUE, ESPECIALLY WITH THE MALE PATIENTS. FOLEYS WERE LEAKING AROUND THE INSERTION SITE AND THE PATIENT'S HAD REPORTED MORE BLADDER SPASMS AND PAIN. THEY HAVE TRIED MULTIPLE THINGS LIKE SWITCHING OUT THE FOLEY'S, OR DEFLATING THE BALLOON AND ADDING MORE FLUID IN THE BALLOON BUT THEY CONTINUED TO LEAK. PER EMAIL FROM CUSTOMER ON (B)(6) 2019, THERE WAS NOT AN EXACT NUMBER AVAILABLE.

  Patient problems: Muscle Spasm(s); Pain

  MAUDE report 9145435 ↗