Bard® Dual Lumen Ureteral Catheter 130200Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741052903), received between Jul 10, 2019 and Jul 18, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT STAFF PLACED AN INDWELLING DOUBLE LUMEN CATHETER. THE FOLEY WAS NOT TESTED PRIOR TO PLACEMENT. THE NURSE PLACED THE CATHETER AFTER EPIDURAL WAS PLACED, INFLATED THE BALLOON WITHOUT ISSUES NOTED AT THE TIME, AND GENTLY PULLED ON THE TUBING TO CHECK PLACEMENT. THE CATHETER WAS THEN SECURED TO THE PATIENT¿S LEG WITH THE STATLOCK FOLEY STABILIZATION DEVICE. THE URETERAL CATHETER WAS FOUND IN THE PATIENT¿S BED BY THE PHYSICIAN WHEN PERFORMING A CERVICAL CHECK. BALLOON WAS DEFLATED AND HAD NO APPARENT DAMAGE TO CATHETER OR TIP. ON FURTHER INVESTIGATION BY THE NURSE, THE BALLOON WAS INFLATED AGAIN, AND A LEAK IN THE TUBING RIGHT BELOW THE BALLOON WAS NOTED. THE LEAK WAS A TINY PINHOLE WHICH WAS NOT VISIBLE UNTIL THE BALLOON WAS FULLY INFLATED. WHEN DONE SO, THERE WAS A NOTABLE THIN STREAM OF WATER THAT WAS VIABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19771303 ↗
• MalfunctionNov 9, 2023Material Fragmentation; Material Twisted/Bent; Material Fragmentation; Material Twisted/Bent

  IT WAS REPORTED THAT TIP OF URETERAL CATHETER WAS SMASHED DOWN OR DEFECTIVE. STAFF WERE NOT ABLE TO INSERT GUIDEWIRE AS THEY USUALLY CAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18104240 ↗
• MalfunctionJul 10, 2019Leak/Splash

  IT WAS REPORTED THAT THE CATHETER LEAKED.

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

  MAUDE report 8776094 ↗
• MalfunctionJul 10, 2019Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem; Inadequate Instructions for Healthcare Professional

  IT WAS REPORTED THAT THE INSTRUCTIONS ON THE DEVICE WERE INADEQUATE. THE CUSTOMER ALLEGED THE INSTRUCTIONS FOR USE DESCRIBED THE DEVICE ITSELF AND PRODUCT WARNINGS BUT VERY LITTLE ABOUT POTENTIAL CLINICAL APPLICATION.

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

  MAUDE report 8775997 ↗