Bard® Center Entry Foley Tray with Bardex® All Silicone Foley Catheter 897416Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741020292), received between Jun 25, 2020 and Jun 25, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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.

• MalfunctionJun 25, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT THE FOLEY CATHETER IN THE KIT WAS KINKED AND IT MAKES HARDER FOR URINE TO DRAIN INTO THE BAG. AS PER ADDITIONAL INFORMATION, THE KINK WAS FOUND ON THE TUBING WHICH CONNECTS THE CATHETER AND THE DRAINBAG.

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

  MAUDE report 10194698 ↗