Bardex® I.C. Foley Catheter 1857SI24Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741017377), received between Oct 21, 2022 and May 10, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (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.

• MalfunctionMay 10, 2026Complete Blockage

  IT WAS REPORTED BY CUSTOMER THAT THE 24 FR HEMATURIA CATHETER WITH IRRIGATION PORT CLOGGED WITH SOMETHING COULD BE FILM OR NOT WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25133599 ↗
• MalfunctionOct 21, 2022Missing Information; Missing Information

  IT WAS REPORTED THAT THE OUTER FOLEY CATHETER PRODUCT PACKAGING LISTED COUDE FOR 1857SI24 5-PACK ,BUT THE INDIVIDUAL ITEMS DID NOT, SO IT MIGHT CAUSE CUSTOMER CONFUSION IF SEPARATED FROM THE OUTER PACKAGE. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 26OCT2022, IT WAS REPORTED THAT THERE WAS NO PATIENT HARM AND THE NURSES DID NOT KNOW TO USE IT SINCE DID NOT SAY COUDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15649871 ↗