Bardex® All-Silicone Foley Catheter 166820Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741029820), received between Jan 23, 2018 and Oct 22, 2024 — classified as 1 injury, 5 malfunctions.

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

• MalfunctionOct 22, 2024Material Invagination; Material Invagination

  IT WAS REPORTED THAT IN (B)(6) 2021 PATIENT HAD A PROSTATE OPERATION WHICH REQUIRED AN OVERNIGHT FOLEY CATHETER. WHEN THE NURSE ATTEMPTED TO REMOVE THE CATHETER, THE NURSE COULD NOT, A SECOND NURSE WAS CALLED WHO COULD NOT EITHER, THEN A DOCTOR WHO COULDN¿T. THE VARIOUS ATTEMPTS TO REMOVE WERE EXTREMELY PAINFUL. THEY FINALLY WITH GREAT EFFORT AND PAIN FOR PATIENT PULLED IT OUT BUT IT SPLIT THE TOP OF PATIENT'S PENIS. THEY SAID IT LOOKED LIKE THE COATING ON THE OUTSIDE OF CATHETER HAD DETACHED AND WRINKLED UP. NOT JUST FOR PAIN AT TIME BUT PATIENT LIFE FELL APART POST OPERATION, THE DELAY IN RECOVERY CAUSED PATIENT TO FALL INTO DEEP DEPRESSION, AND POST OPERATION, PATIENT STILL HAVE A DULL PAIN IN WHICH THE PATIENT THOUGHT MAYBE RELATED TO DAMAGE CAUSED BY REMOVAL. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 20504918 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WITH SPINA BIFIDA TO EMERGENCY DEPARTMENT WITH URINARY TRACT INFECTION. INDWELLING CATHETER REMOVED WAS GUNKY. BARDEX ALL-SILICONE FOLEY CATHETER INSERTED AND DRAINED 20CC. BLADDER SCAN REVEALED 160CC IN BLADDER AND ATTEMPTED TO IRRIGATE CATHETER WITHOUT SUCCESS. FOLEY WAS REMOVED AND ANOTHER ONE TRIED, DRAINED DARK RED URINE WITH SMALL CLOT AND THERE WAS NO KNOWN HARM TO PATIENT. PER FOLLOW UP 12APR2024, ISSUE WAS NOT NOTICED PRIOR TO USE AND PATIENT STATUS WAS UNKNOWN AT THIS TIME.

  Patient problems: Urinary Tract Infection

  MAUDE report 18845547 ↗
• MalfunctionNov 12, 2019Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE HOSPITAL RECEIVED 18F CATHETERS INSTEAD OF 20FR CATHETERS AS THE LABEL STATED.

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

  MAUDE report 9310194 ↗
• MalfunctionJul 2, 2019Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE OUTER PACKAGING WAS LABELED FOR REFERENCE NUMBER (B)(4) BUT THE REFERENCE NUMBER ON THE INSIDE OF THE PACKAGING WAS (B)(4).

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

  MAUDE report 8754768 ↗
• MalfunctionMar 20, 2018Break; Detachment Of Device Component

  IT WAS REPORTED THAT THE TIP OF THE CATHETER BROKE OFF. IT WAS LATER REPORTED THAT THE LUMEN OF THE BALLOON DETACHED FROM THE CATHETER. THE EVENT HAPPENED OUTSIDE OF THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7353707 ↗
• MalfunctionJan 23, 2018Break; Detachment Of Device Component

  IT WAS REPORTED THAT THE TIP OF THE CATHETER BROKE OFF. THIS WAS THE SECOND INCIDENT WITH THIS PRODUCT. IT WAS LATER REPORTED, THE LUMEN OF THE BALLOON HAD DETACHED FROM THE CATHETER, OUTSIDE OF THE PATIENT.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7213831 ↗