BRITE TIP 401555MRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705032000215), received between Aug 4, 2021 and Aug 4, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Frayed” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2021Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE 5F 55CM BRITE TIP CATHETER SHEATH INTRODUCER (CSI) WAS INSERTED BUT THE DISTAL END FRAYED. THERE WAS NO REPORTED PATIENT INJURY. THE DAMAGE WAS NOTICED WHEN THE DEVICE WAS BEING INSERTED INTO THE PATIENT. THERE WAS NO REPORTED DAMAGE TO THE PACKAGING. THE PRODUCT WAS STORED IN THE BOX WITHIN THE LAB. NO ANOMALIES WERE NOTED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE. THE DEVICE WAS NOT REMOVED FROM PACKAGING BY PULLING ON THE HUB. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY NOTED DURING PREP. THE FEMORAL ARTERY WAS USED FOR ACCESS DURING THE PROCEDURE. THE VESSEL WAS NOT PRE-DILATED. THE INTENDED TARGET/LESION WAS IN THE INTERNAL ILIAC. THERE WAS NO RESISTANCE/FRICTION NOTED WHILE ADVANCING THROUGH THE SHEATH. THE PUNCTURE SITE DID NOT HAVE ANY VISIBLE PLAQUE/CALCIUM. THE CASE WAS COMPLETED AFTER USE OF A NON-CORDIS DEVICE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12275955 ↗