Bardex® Lubri-Sil® All-Silicone Foley Catheter 73024LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741034336), received between Jan 5, 2021 and Oct 21, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT IN THE EMERGENCY DEPARTMENT, RN PLACED A 3-WAY THIS MORNING FOR IRRIGATION, AND AFTER RN HOOKED EVERYTHING UP, NOTICED IT WAS LEAKING DUE TO A SMALL TEAR ON THE CATHETER ALONG THE SEAM LINE. RN SAID THE PACKAGING WAS ALL INTACT BEFORE INSERTION AND DID NOT DEVIATE FROM STANDARD INSERTION PROCEDURES. THEY REMOVED THE REST OF THE CATHETERS WITH THAT LOT NUMBER IN OUR STOCK AND LET OUR MATERIALS COORDINATOR KNOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23349304 ↗
• MalfunctionOct 2, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT HAIR WAS FOUND INSIDE ONE OF THE EA AND SMALL PARTICLES IN THE REST OF THEIR ON-HAND INVENTORY (59 EA) FOR THIS ITEM. IN TOTAL, THEY HAD 60 EA (5 CA) THAT WERE AFFECTED WITH LOT # NGKQ2761. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 25JUN2025, IT WAS REPORTED THAT THE LOT NUMBER FOR THE FAULTY CATHETERS RETURNED BY OUR PATIENT IN OUR PREVIOUS CONVERSATION WAS RECORDED INCORRECTLY. IT SHOULD BE LOT: NGJS5061. PER INVESTIGATOR NOTIFICATION RECEIVED VIA TASK ON 29SEPT2025, IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND IN THE ADDITIONAL SAMPLE RECEIVED. MATERIAL#73024L AND THE LOT NGKQ2761.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23199219 ↗
• MalfunctionJun 18, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHILE DOING A CYCLE COUNT, THEY NOTICED THAT ITEM 168394 HAD SOME HAIR AND SOME SORT OF DIRT INSIDE THE CATHETER LOT # NGKQ2761.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22284669 ↗
• MalfunctionAug 24, 2023Material Invagination; Material Invagination

  IT WAS REPORTED THAT THERE WAS RIDGING OF THE BALLOON WHEN REMOVING THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17611233 ↗
• MalfunctionJan 5, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CATHETER WAS GETTING CAUGHT OR LODGED ON REMOVAL WHICH CAUSED PAIN TO THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED. PER ADDITIONAL INFORMATION RECEIVED VIA IBC ON 18JAN2021, IT WAS UNKNOWN HOW THE CATHETER WAS REMOVED. PATIENT STATUS WAS UNKNOWN.

  Patient problems: Pain

  MAUDE report 11120416 ↗