Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1768SI22Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741025303), received between Jun 18, 2018 and Jul 8, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON JUST DEFLATED, AND IT DID NOT FALL OUT, SO THEY WERE NOT AWARE THAT THE PATIENT WAS NOT ABLE TO VOID AND HAD ENDED UP IN THE HOSPITAL WITH UROSEPSIS. IT WAS NOTED THAT THIS HAPPENED WITH 2 FOLEYS WITH SAME LOT NUMBERS. PER CUSTOMER ON (B)(6)2024, IT WAS REPORTED THAT IN (B)(6) PATIENT EXPERIENCED A DEFLATED BALLOON BUT WAS UNAWARE BECAUSE IT DID NOT FALL OUT. CUSTOMER NOTICED THAT HE HAD NOT VOIDED IN 9 HOURS AND THE CATHETER WAS NOT DRAINING. CUSTOMER WAS HOSPITALIZED ON (B)(6) 2024 AND WAS DIAGNOSED WITH URO-SEPSIS. MEDICAL INTERVENTION WAS REPORTED AND CUSTOMER RECEIVED IV ANTIBIOTICS TO TREAT THE INFECTION. THE SECOND OCCURRENCE HAPPENED ON (B)(6)2024 WITH THE SAME LOT# NGHV2411 WHICH WAS REPORTED FOR BOTH EVENTS.

  Patient problems: Sepsis

  MAUDE report 19691043 ↗
• InjuryJul 2, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON JUST DEFLATED, AND IT DID NOT FALL OUT SO THEY WERE NOT AWARE THAT THE PATIENT WAS NOT ABLE TO VOID AND HAD ENDED UP IN THE HOSPITAL WITH UROSEPSIS. IT WAS NOTED THAT THIS HAPPENED WITH 2 FOLEYS WITH SAME LOT NUMBERS. PER CUSTOMER ON (B)(6) 2024, IT WAS REPORTED THAT IN FEBRUARY, PATIENT EXPERIENCED A DEFLATED BALLOON BUT WAS UNAWARE BECAUSE IT DID NOT FALL OUT. CUSTOMER NOTICED THAT THEY HAD NOT VOIDED IN 9 HOURS AND THE CATHETER WAS NOT DRAINING. CUSTOMER WAS HOSPITALIZED ON (B)(6) 2024 AND WAS DIAGNOSED WITH URO-SEPSIS. MEDICAL INTERVENTION WAS REPORTED AND CUSTOMER RECEIVED IV ANTIBIOTICS TO TREAT THE INFECTION. THE SECOND OCCURRENCE HAPPENED ON (B)(6) 2024 WITH THE SAME LOT# NGHV2411 WHICH WAS REPORTED FOR BOTH EVENTS.

  Patient problems: Sepsis

  MAUDE report 19656750 ↗
• InjuryJun 18, 2018Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A URINARY TRACT INFECTION DURING USE OF THE CATHETER. ALLEGEDLY, THE PATIENT WAS PRESCRIBED AN ANTIBIOTIC CALLED LEVOFLOXACIN.

  Patient problems: Urinary Tract Infection

  MAUDE report 7610186 ↗