BRITE TIP 401605MRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705032000222), received between Dec 5, 2023 and Sep 30, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 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.

• InjurySep 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A SINGLE CD-ROM CONTAINING 12 IMAGES WAS SUBMITTED FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20332913 ↗
• InjurySep 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE TIP OF THE 6F 5.5CM BRITE TIP SHEATH INTRODUCER BROKE; THE RADIOPAQUE TIP SEPARATED FROM THE REST OF THE CATHETER AND EMBEDDED IN THE PATIENT, RESULTING IN TWO PIECES. THERE WAS NO REPORTED PATIENT INJURY. NO ANOMALIES WERE NOTED WHEN THE PRODUCT WAS REMOVED FROM THE PACKAGE. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND IT WAS INSPECTED AND PREPPED PER THE IFU WITHOUT ANY DIFFICULTY. NO RESISTANCE OR FRICTION WAS EXPERIENCED DURING ANY PART OF THE PROCEDURE, AND NO RESISTANCE WAS MET WHILE ADVANCING THE DEVICE. UNUSUAL FORCE WAS NOT NECESSARY DURING THE USE OF THE DEVICE, AND EXCESSIVE TORQUING WAS NOT REQUIRED. THE TIP WAS VISIBLE ON FLUOROSCOPY THROUGHOUT THE PROCEDURE. THE EXAM WAS COMPLETE AT THIS POINT, AND ANOTHER BRITE TIP SHEATH WAS NOT USED. THE CUSTOMER PULLED THE BOX OFF THE SHELF AND DID NOT CONFIRM IF THEY WOULD BE RETURNING THE UNUSED UNITS LEFT IN THE BOX OR IF THEY WANTED A CREDIT OR REORDER. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20295408 ↗
• MalfunctionDec 5, 2023Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED A 6F 5.5CM BRITE TIP SHEATH INTRODUCER WAS FRAYED. THE SHEATH WAS REMOVED, AND THE ACCESS SITE WAS CLOSED NORMALLY. THERE WERE NO REPORTS OF PATIENT INJURY AND NOTHING EMBOLIZED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18267939 ↗