Bardex® Lubri-Sil® All-Silicone Foley Catheter 73020LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741034312), received between Apr 18, 2025 and Jun 23, 2025 — classified as 3 malfunctions.

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.

• MalfunctionJun 23, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CUSTOMER CONTACTED REGARDING A MATERIAL SAFETY REPORT CONCERNING FOLEY SILICONE 3-WAY CH18 PROBES, REFERENCE: 73018CAE, BATCH: NGHQ0771. THE PROBLEM RAISED OCCURRED ON TWO OCCASIONS, A PATIENT WAS CATHETERIZED WITH A CATHETER FOR BLADDER LAVAGE. THE CATHETER DID NOT STAY IN PLACE AND THE BALLOON WAS FOUND TO BE DEFLATED AND LEAKING AFTER REMOVAL. THIS LED TO SEVERAL CATHETERIZATIONS, WHICH ENDED UP BEING TRAUMATIC. ON THE OTHER HAND, THE PATIENT HAD NO PARTICULAR OBSTACLE, AND THERE WERE NO HANDLING PROBLEMS AS NURSE WHO HAD ALREADY PERFORMED THE PROCEDURE, DOCTOR PRESENT, PATIENT COOPERATIVE (LOT#: NGHQ0771). A NEW INCIDENT OCCURRED AGAIN WITH THE SAME PATIENT WITH A 3V CH20 PROBE, REFERENCE: 73020CE AND DID NOT HAVE A SAMPLE FOR THIS PROBE (LOT#: NGHP0228). PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 06JUN2025, THE PATIENT HAD TO BE TREATED AGAIN, WHICH BECAME TRAUMATIC. THE PROCEDURE WAS UNCOMFORTABLE AND CAUSES A LOSS OF TIME AND STRESS. THE EVENT OCCURRED FIRST TIME WAS ON 30MAY2025, AND THE SECOND TIME WAS SHORTLY AFTERWARDS ON THE SAME DAY. THE TWO PROBES THAT BECAME MISALIGNED WERE DISCARDED BY THE DEPARTMENT. HOWEVER, HAVE SEVERAL NEW PROBES FROM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308637 ↗
• MalfunctionJun 23, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CUSTOMER CONTACTED REGARDING A MATERIAL SAFETY REPORT CONCERNING FOLEY SILICONE 3-WAY CH18 PROBES, REFERENCE (B)(4), BATCH NGHQ0771. THE PROBLEM RAISED OCCURRED ON TWO OCCASIONS, A PATIENT WAS CATHETERIZED WITH A CATHETER FOR BLADDER LAVAGE. THE CATHETER DID NOT STAY IN PLACE AND THE BALLOON WAS FOUND TO BE DEFLATED AND LEAKING AFTER REMOVAL. THIS LED TO SEVERAL CATHETERIZATIONS, WHICH ENDED UP BEING TRAUMATIC. ON THE OTHER HAND, THE PATIENT HAD NO PARTICULAR OBSTACLE, AND THERE WERE NO HANDLING PROBLEMS AS NURSE WHO HAD ALREADY PERFORMED THE PROCEDURE, DOCTOR PRESENT, PATIENT COOPERATIVE (LOT# NGHQ0771) AND (LOT# UNK). A NEW INCIDENT OCCURRED AGAIN WITH THE SAME PATIENT WITH A 3V CH20 PROBE, REFERENCE (B)(4) AND DID NOT HAVE A SAMPLE FOR THIS PROBE (LOT# NGHP0228) AND (LOT# UNK). PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON (B)(6) 2025, THE PATIENT HAD TO BE TREATED AGAIN, WHICH BECAME TRAUMATIC. THE PROCEDURE WAS UNCOMFORTABLE AND CAUSES A LOSS OF TIME AND STRESS. THE EVENT OCCURRED FIRST TIME WAS ON (B)(6) 2025, AND THE SECOND TIME WAS SHORTLY AFTERWARDS ON THE SAME DAY. THE TWO PROBES THAT BECAME MISALIGNED WERE DISCARDED BY THE DEPARTMENT. HOWEVER, HA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308636 ↗
• MalfunctionApr 18, 2025Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  IT WAS REPORTED THAT DUE TO CUSTOMER BACKORDER ON FOLEY CATHETER, THEY USED A DIFFERENT FRENCH SIZE DURING A PROCEDURE AND DUE TO DIFFICULTY PLACING THE PATIENT WAS REQUIRED TO STAY UNDER ANESTHESIA LONGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21868593 ↗