Brite Tip Radianz 687280135Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032081211), received between Mar 4, 2023 and Jul 15, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2025Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE INSERTION OF THE 6F 135CM BRITE TIP RADIANZ GUIDING SHEATH AT THE SUPERFICIAL FEMORAL ARTERY (SFA) VIA RADIAL APPROACH WAS DIFFICULT AND THE TIP BECAME FRAYED. A 6F 110CM BRITE TIP RADIANZ GUIDING SHEATH WAS USED INSTEAD. INSERTION WAS SUCCESSFUL AND THE PROCEDURE CONTINUED. THERE WERE NO REPORTS OF PATIENT INJURY. NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22516563 ↗
• MalfunctionMar 4, 2023Difficult to Remove; Difficult to Remove

  AS REPORTED, THE HEMOSTASIS VALVE ON A 135 CM BRITE TIP RADIANZ GUIDING SHEATH CAME OFF AS THE PHYSICIAN WAS REMOVING THE SHEATH. THE DIFFICULTIES ENCOUNTERED DURING THE INSERTION PROCESS WERE REFLECTIVE OF THE FACT THAT THE PATIENT HAD SMALL VESSELS. THERE WAS SLIGHT RESISTANCE ENCOUNTERED DURING THE WITHDRAWAL PROCESS. THERE WERE NO REPORTS OF PATIENT INJURY. THERE WERE ATTEMPTS AT RECONNECTING THE REMOVABLE VALVE, WITHOUT SUCCESS. THE CASE WAS COMPLETED WITHOUT OTHER PRODUCTS AND NO OTHER ISSUES WERE FOUND. THE VESSEL DILATOR WAS NOT SNAPPED INTO PLACE AT THE HUB AT THE TIME OF REMOVAL. THE ACCESS SITE VESSELS HAD NO CALCIFICATION OR TORTUOSITY. THE DEVICE WAS FLUSHED PRIOR TO USE. THE DEVICE/PACKAGING WAS NOT DAMAGED PRIOR TO UTILIZING THE DEVICE. THE USER IS TRAINED TO THE DEVICE. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, NOT ANSWERED, OR NOT APPLICABLE. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483473 ↗