Bardex® Lubri-Sil® All-Silicone Foley Catheter 73018LRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741034305), received between Jan 3, 2018 and Jun 25, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 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) 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 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 (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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort

  MAUDE report 22328010 ↗
• InjuryJun 25, 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) 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 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

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

  MAUDE report 22327998 ↗
• MalfunctionOct 9, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INDWELLING FOLEY CATHETER WAS LEAKING. SEVERAL OF THESE CATHETERS WERE INSERTED INTO AN ANESTHETIZED PATIENT IN THE MORNING, BOTH OF WHICH HAD THE SAME ISSUE. BOTH HAD A SMALL HOLE AT THE TOP OF THE CATHETER, THIS WAS NOT THE END THEY PUT IN TO THE PATIENT. WHEN THE USER WENT TO CHECK THE STOCK, IT WAS FOUND THAT BOTH THE CATHETERS WERE USED AND HAD THE SAME BATCH NUMBER. SINCE THE USER HAD NO OTHER STOCK, A DIFFERENT NOT SO SUITABLE CATHETER HAD TO BE USED. THIS FAULT ISSUE NOT ONLY RESULTED IN MULTIPLE CATHETERS BEING INSERTED, BUT ALSO DELAYED THE PATIENT ADDITIONAL TREATMENT. BOTH REMAINING BOXES WERE TAKEN OFF THE SHELF AND QUARANTINED. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 28AUG2023, STATED THAT ALL FAULTY DEVICES WERE USED ON THE SAME PATIENT. THE PATIENT DELAY WAS GETTING THEM OFF THE TABLE AS THEY HAD TO REPLACE THE CATHETER THREE TIMES. THE PATIENT STATUS WAS DISCHARGED HOME. PER MAIL RECEIVED ON 13SEP2023, STATED THAT THE CUSTOMER RETURNED AN ADDITIONAL USED SAMPLE.

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

  MAUDE report 17894308 ↗
• MalfunctionSep 13, 2023Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE BALLOON WAS RIDGED WHEN THE FOLEY CATHETER WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17737506 ↗
• MalfunctionSep 8, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INDWELLING FOLEY CATHETER WAS LEAKING. SEVERAL OF THESE CATHETERS WERE INSERTED INTO AN ANESTHETIZED PATIENT IN THE MORNING, BOTH OF WHICH HAD THE SAME ISSUE. BOTH HAD A SMALL HOLE AT THE TOP OF THE CATHETER, THIS WAS NOT THE END THEY PUT IN TO THE PATIENT. WHEN THE USER WENT TO CHECK THE STOCK, IT WAS FOUND THAT BOTH THE CATHETERS WERE USED AND HAD THE SAME BATCH NUMBER. SINCE THE USER HAD NO OTHER STOCK, A DIFFERENT NOT SO SUITABLE CATHETER HAD TO BE USED. THIS FAULT ISSUE NOT ONLY RESULTED IN MULTIPLE CATHETERS BEING INSERTED, BUT ALSO DELAYED THE PATIENT ADDITIONAL TREATMENT. BOTH REMAINING BOXES WERE TAKEN OFF THE SHELF AND QUARANTINED. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 28AUG2023, STATED THAT ALL FAULTY DEVICES WERE USED ON THE SAME PATIENT. THE PATIENT DELAY WAS GETTING THEM OFF THE TABLE AS THEY HAD TO REPLACE THE CATHETER THREE TIMES. THE PATIENT STATUS WAS DISCHARGED HOME. PER MAIL RECEIVED ON 13SEP2023, STATED THAT THE CUSTOMER RETURNED AN ADDITIONAL USED SAMPLE.

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

  MAUDE report 17711896 ↗
• MalfunctionAug 10, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT CUSTOMER USED THREE FOLEY CATHETERS AND EACH HAD A SPLIT NEAR THE THREE-WAY CONNECTOR. STATED THAT THE PRODUCT DID NOT WORKED AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17500211 ↗
• MalfunctionMar 18, 2020Collapse; Material Invagination; Difficult to Remove; Material Invagination

  IT WAS REPORTED WHEN A FOLEY CATHETER WAS REMOVED IT WAS FOUND THAT THE BALLOON HAD COLLAPSED ON ITSELF. IT WAS ALSO NOTED THAT A RING HAD DEVELOPED AROUND THE END OF THE FOLEY BY THE BALLOON, WHICH MADE IT DIFFICULT TO REMOVE. THE RAPID RESPONSE NURSE MENTIONED THAT SHE HAD SEEN IT HAPPENED BEFORE, BUT NEVER REPORTED IT.

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

  MAUDE report 9848392 ↗
• MalfunctionJan 3, 2018Fluid/Blood Leak; Hole In Material

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE TUBING OF THE CATHETER WHICH CAUSED URINE TO LEAK. THE COMPLAINANT REPORTEDLY REPLACED THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7161567 ↗