Bard® Silastic® Foley Catheter 33426Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741020032), received between Feb 27, 2023 and Feb 27, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inadequate Instructions for Healthcare Professional” (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.

• MalfunctionFeb 27, 2023Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional

  IT WAS REPORTED THAT THE PATIENT ORDERED TO HAVE A 26FR URETHRAL CATHETER EXCHANGED. THE CATHETER WAS EXCHANGED USING STERILE TECHNIQUE. URINE RETURN WAS OBSERVED. UPON INFLATING BALLOON STERILE WATER SPRAYED OUT OF THE PORT ABOVE WHERE THE SYRINGE WAS ATTACHED, AND THE REGISTERING NURSE OBSERVED THAT THAT PIECE WAS DRY ROTTED, SO THE CATHETER WAS PROMPTLY REMOVED FROM THE PATIENT. AFTER REMOVAL, THE PACKAGING WAS INSPECTED FOR AN EXPIRATION DATE BY MULTIPLE REGISTERED NURSES. THERE WAS NO EXPIRATION DATE ON THE CATHETER OR PACKAGING. EXTERNAL CATHETER PLACED ON THE PATIENT UNTIL ANOTHER CATHETER COULD BE OBTAINED. ALTHOUGH NO PATIENT HARM OCCURRED, THE PATIENT WOULD HAVE TO HAVE A SECOND INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444850 ↗
• MalfunctionFeb 27, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT ORDERED TO HAVE A 26FR URETHRAL CATHETER EXCHANGED. THE CATHETER WAS EXCHANGED USING STERILE TECHNIQUE. URINE RETURN WAS OBSERVED. UPON INFLATING BALLOON STERILE WATER SPRAYED OUT OF THE PORT ABOVE WHERE THE SYRINGE WAS ATTACHED, AND THE REGISTERING NURSE OBSERVED THAT THAT PIECE WAS DRY ROTTED, SO THE CATHETER WAS PROMPTLY REMOVED FROM THE PATIENT . AFTER REMOVAL, THE PACKAGING WAS INSPECTED FOR AN EXPIRATION DATE BY MULTIPLE REGISTERED NURSES. THERE WAS NO EXPIRATION DATE ON THE CATHETER OR PACKAGING. EXTERNAL CATHETER PLACED ON THE PATIENT UNTIL ANOTHER CATHETER COULD BE OBTAINED. ALTHOUGH NO PATIENT HARM OCCURRED, THE PATIENT WOULD HAVE TO HAVE A SECOND INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16443065 ↗