Bard® Foley Catheter Silicone Coated 266726Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741039744), received between Aug 1, 2020 and Jun 26, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Infuse” (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.

• MalfunctionJun 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE NURSE HAD A FOLEY CATHETER (266726), STATED LABEL ISSUE DATE 10/97. STATED THAT THEY PRETESTED THE BALLOON AND WHEN THEY DID IT DISINTEGRATED. LOT: 87HNR116. EXPLAINED THE LABEL ISSUE DATE WHEN THE LABEL WAS CREATED. THIS ITEM WAS MANUFACTURED IN AUGUST 2003. EXPLAINED HOW IT HAD A SHELF LIFE OF FIVE YEARS, AND THEY CANNOT RECOMMEND USE BEYOND THIS. CUSTOMER WAS NOT HAPPY THERE WAS NO EXPIRATION DATE. EXPLAINED MOST PRODUCTS GOING FORWARD WOULD HAVE AN EXPIRATION DATE ON THE PACKAGING, BUT THOSE OLDER PRODUCTS MAY NOT. FORWARDED TO COMPLAINTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337345 ↗
• MalfunctionAug 1, 2020Failure to Infuse; Therapeutic or Diagnostic Output Failure; Failure to Infuse

  IT WAS REPORTED THAT 3 BARD FOLEY CATHETERS WERE INJECTED WITH SALINE TO INFLATE THE BALLOON, AND IT WAS NOTED THAT THE CATHETERS BALLOONED OUT AT THE DISTAL END JUST PAST THE LOCATION WHERE THE SYRINGE ATTACH.

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

  MAUDE report 10354137 ↗