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VISTA BRITE TIP 77805800Recalls & reported problems

Cordis Corporation · GC 7F 078 XB 4.5 · Class 2

All models of VISTA BRITE TIP (26)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 20705032021910), received between Aug 3, 2023 and Aug 3, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (1 report).

1 other recall cover devices cleared under the same FDA submission (K963962); they may or may not involve this specific model.

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

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.

  • MalfunctionAug 3, 2023Crack; Crack

    AS REPORTED, THE BODY SHAFT OF A 7F VISTA BRITE TIP EXTRA BACK-UP 4.5 GUIDING CATHETER WAS FOUND FRACTURED DURING USE IN A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE OPERATOR HAS EXTENSIVE CLINICAL SURGICAL EXPERIENCE. THE PRODUCT WAS STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE TIP OF THE DEVICE WAS VISIBLE UNDER FLUOROSCOPY THROUGHOUT THE PROCEDURE. ADDITIONAL EVENT DETAILS WERE REQUESTED; HOWEVER, NOT PROVIDED. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17455504 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K963962. One submission often covers many models, so check the product and lot details in each record.

  • Z-1198-2019 · Feb 7, 2019 · Terminated
    Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices i

Other CATHETER, PERCUTANEOUS devices

All CATHETER, PERCUTANEOUS devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page