Bardex® Silicone Coated Foley Catheter 0165V22SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741039423), received between Jan 28, 2019 and Oct 12, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE CUSTOMER NOTICED SOMETHING IN THE MIDDLE OF THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15587091 ↗
• MalfunctionMay 20, 2022Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WOULD NOT BE INFLATED AND HAD TO USE A NEW CATHETER. PATIENT EXPERIENCED INCONVENIENCE AND NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 14454955 ↗
• MalfunctionJan 15, 2020Material Twisted/Bent; Packaging Problem

  IT WAS REPORTED THAT THE FOLEY CATHETERS WERE SHIPPED IN A BOX THAT WAS TOO SMALL AND THE PRODUCT WAS TWISTED AND BENT IN HALF. THEY WERE UNABLE TO BE USED UPON ARRIVAL. THIS WAS THE 3RD OCCURRENCE.

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

  MAUDE report 9591392 ↗
• MalfunctionJan 15, 2020Material Twisted/Bent; Packaging Problem

  IT WAS REPORTED THAT THE FOLEY CATHETERS WERE SHIPPED IN A BOX THAT WAS TOO SMALL. THE PRODUCT WAS TWISTED AND BENT IN HALF. THEY WERE UNABLE TO BE USED UPON ARRIVAL. THIS WAS THE 3RD OCCURRENCE.

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

  MAUDE report 9591287 ↗
• MalfunctionJan 28, 2019Inaccurate Flow Rate; Patient-Device Incompatibility; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE CATHETER HAD TO BE REMOVED AFTER 3.5 DAYS IN USE DUE TO GROWING DISCOMFORT. THE PATIENT'S WIFE REPORTED THAT THE CATHETER BEGAN TO CLOG UP AND WOULD NOT DRAIN. THE PATIENT'S WIFE COULD NOT IDENTIFY WHAT WAS CLOGGING THE CATHETER OR WHAT PROMPTED IT. THE WIFE WAS ABLE TO CHANGE THE CATHETER WITHOUT ANY MEDICAL INTERVENTION.

  Patient problems: Discomfort

  MAUDE report 8282213 ↗