Bardex® Silicone Coated Foley Catheter 0165V24SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741039430), received between Nov 6, 2017 and Jun 3, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT PATIENT ARRIVED IN EMERGENCY ROOM, FOLEY CATHETER JUST FELL OUT THIS MORNING. PATIENT HAD UROLOGY SURGERY LAST WEEK, WENT HOME WITH A FOLEY. UROLOGIST REQUESTED A REPLACEMENT FOLEY. NURSE NOTICED THE FOLEY THAT WIFE BROUGHT FROM HOME DID NOT HAVE THE TIP INTACT, PALPATED THE PENIS AND ALL COULD FEEL THE CATHETER WITHIN THE URETHRA. PA GENTLY WORKED TO BROKEN CATHETER TO WHERE IT WAS VISUALIZED AND REMOVED WITHOUT COMPLICATIONS. NEW INTACT FOLEY WAS INSERTED WITHOUT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19446389 ↗
• InjuryMay 31, 2024Material Fragmentation; Material Puncture/Hole; Material Fragmentation; Material Puncture/Hole

  IT WAS REPORTED THAT PATIENT ARRIVED IN EMERGENCY ROOM, FOLEY CATHETER JUST FELL OUT THIS MORNING. PATIENT HAD UROLOGY SURGERY LAST WEEK, WENT HOME WITH A FOLEY. UROLOGIST REQUESTED A REPLACEMENT FOLEY. NURSE NOTICED THE FOLEY THAT WIFE BROUGHT FROM HOME DID NOT HAVE THE TIP INTACT, PALPATED THE PENIS AND ALL COULD FEEL THE CATHETER WITHIN THE URETHRA. PA GENTLY WORKED TO BROKEN CATHETER TO WHERE IT WAS VISUALIZED AND REMOVED WITHOUT COMPLICATIONS. NEW INTACT FOLEY WAS INSERTED WITHOUT COMPLICATIONS.

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

  MAUDE report 19434377 ↗
• InjuryMay 14, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT PATIENT ARRIVED IN EMERGENCY ROOM, FOLEY CATHETER JUST FELT OUT THAT MORNING. PATIENT HAD UROLOGY SURGERY LAST WEEK ON (B)(6) 2024, WENT HOME WITH A FOLEY. UROLOGIST REQUESTED A REPLACEMENT FOLEY. EMERGENCY ROOM NURSE NOTICED THE FOLEY THAT BROUGHT FROM HOME DID NOT HAVE THE TIP INTACT. PALPATED THE PENIS, AND ALL THEY COULD FEEL THE CATHETER WITHIN THE URETHRA. PHYSICIAN ASSISTANT GENTLY WORKED ON BROKEN CATHETER TO WHERE IT WAS VISUALIZED AND REMOVED WITHOUT COMPLICATIONS. THEY HAD TO SURGICALLY REMOVE BROKEN CATHETER FROM PATIENT. NEW INTACT FOLEY WAS INSERTED WITHOUT COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 19309856 ↗
• MalfunctionApr 6, 2021Decrease in Pressure; Dent in Material; Decrease in Pressure; Dent in Material

  IT WAS REPORTED THAT THE BALLOON COLLAPSE INTO THE CATHETER AFTER INFLATION. PER FOLLOW UP ON 13APR2021, THE CUSTOMER CONFIRMED THAT THE BALLOON FORMED A MUSHROOM ONCE INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11620300 ↗
• MalfunctionNov 6, 2017Leak/Splash

  IT WAS REPORTED THAT THE CATHETER STOPPED DRAINING URINE WHICH REPORTEDLY LED TO A LEAK. THE PATIENT REPORTEDLY REPLACED THE CATHETER AND VOIDED WITHOUT FURTHER INCIDENT.

  Patient problems: No Information

  MAUDE report 7002789 ↗