Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 73018SIRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741025495), received between Apr 23, 2025 and Sep 3, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Material Puncture/Hole

  It was reported that during use customer observed leakage at the junction of the foley catheter draining site. This appear to be a product defect. this event happened in Operation theatre. They have discarded the catheter once they find leakage on the catheter 18fr 3way silicone.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50578071 ↗
• MalfunctionSep 29, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT, CUSTOMER OBSERVED LEAKAGE AT THE JUNCTION OF THE FOLEY CATHETER DRAINING SITE. THIS APPEAR TO BE A PRODUCT DEFECT. THIS EVENT HAPPENED IN OPERATION THEATRE. LAST EVENT INCIDENT HAPPENED THE SAME LEAKAGE ISSUE WHICH WAS REPORTED ON (B)(6) 2025 IN MEDICAL ICU. THIS INCIDENT WAS SECOND TIME IN THIS HOSPITAL. CATHETER WAS DISCARDED ONCE USER FIND LEAKAGE ON THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23167317 ↗
• MalfunctionAug 18, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT CUSTOMER OBSERVED LEAKAGE AT THE JUNCTION OF THE FOLEY CATHETER CONNECTING SITE. THIS APPEARS TO BE A PRODUCT DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22826980 ↗
• MalfunctionJun 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT POST PROCEDURE HAD TO INSERT THE FOLEY CATHETER, 3 OUT OF FIRST 2 CATHETERS HAD LEAKAGE AT THE IRRIGATION PORT ACCESS PARTS. FOR LOT#NGJR1639 AND LOT#NGJX6161.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338865 ↗
• MalfunctionJun 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT POST PROCEDURE HAD TO INSERT THE FOLEY CATHETER, 3 OUT OF FIRST 2 CATHETERS HAD LEAKAGE AT THE IRRIGATION PORT ACCESS PARTS. FOR LOT#NGJR1639 AND LOT#NGJX6161.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22336715 ↗
• MalfunctionApr 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT CUSTOMER WAS CONTINUING TO HAD PROBLEMS WITH LEAKS IN THEIR FOLEY CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892868 ↗