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Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI22Recalls & reported problems

C. R. Bard, Inc. · Bardex® Lubri-Sil® I.C. All-Silicone Coated 5 cc Foley Catheter · Class 2

All models of Bardex Lubri-Sil I.C. All-Silicone Foley Catheter (26)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741025259), received between Jul 25, 2018 and Apr 25, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Complete Blockage” (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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Complete Blockage1
  • Deflation Problem1
  • Partial Blockage1
  • Patient-Device Incompatibility1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Hemorrhage/Blood Loss/Bleeding1
  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1
  • Patient Problem/Medical Problem1
  • Urinary Tract Infection1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 25, 2023Deflation Problem; Deflation Problem

    IT WAS REPORTED THAT THE FOLEY CATHETER WAS NOT DRAINING. DOCTOR OF MEDICINE ATTEMPTED TO REMOVE CATHETER AFTER BALLOON DEFLATION BUT WAS UNABLE. DOCTOR OF MEDICINE CUT BALLOON FILLING PORT AND BALLOON STAYED INFLATED. DOCTOR OF MEDICINE REMOVED CATHETER WITH INFLATED BALLOON. DOCTOR OF MEDICINE WENT BACK IN WITH CYSTOSCOPE TO ASSURE HOMEOSTASIS AND THEN REPLACED NEW CATHETER WITHOUT DIFFICULTY.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 16806942 ↗
  • InjuryNov 21, 2018Patient-Device Incompatibility; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SELF LIMITED BLEEDING AND A URINARY TRACT INFECTION AFTER INSERTION OF THE 22 FR CATHETER. THE PATIENT WAS TREATED WITH A PRESCRIPTION ANTIBIOTIC FOR THE UTI IN THE EMERGENCY ROOM.

    Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem; Urinary Tract Infection

    MAUDE report 8096805 ↗
  • MalfunctionJul 25, 2018Partial Blockage; Complete Blockage; Partial Blockage

    IT WAS REPORTED THAT THE CATHETER BECAME BLOCKED AND CLOGGED DURING USE. NO MEDICAL INTERVENTION WAS REPORTED.

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

    MAUDE report 7719882 ↗

Other CATHETER, RETENTION TYPE, BALLOON devices

All CATHETER, RETENTION TYPE, BALLOON devices →

Sources and updates

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