Skip to content

BRITE TIP 5560020LRecalls & reported problems

Cordis US Corp. · GC 5F 056 JL 3.5 LBT · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032015186), received between Mar 12, 2021 and Mar 12, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Crack1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionMar 12, 2021Crack; Crack

    AS REPORTED, A 5F .056¿ JUDKIN¿S LEFT 3.5 (JL3.5) LONG VISTA BRITE TIP GUIDING CATHETER WAS CIRCULATED WHEN A FRACTURE WAS OBSERVED IN THE BODY OF THE CATHETER. THEREFORE, THE SPECIALIST REQUESTED A CHANGE OF INPUT AND A NEW UNKNOWN CATHETER WAS CIRCULATED. THE DEVICE HAS NO CONTACT WITH THE PATIENT OR FLUIDS. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS INTENDED TO BE USED IN AN ANGIOPLASTY PROCEDURE. THE DEVICE WAS RETURNED FOR EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11470218 ↗

Other CATHETER, PERCUTANEOUS devices

All CATHETER, PERCUTANEOUS devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.