VISTA BRITE TIP 67008000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032020418), received between Apr 17, 2025 and Apr 17, 2025 — 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

Recent adverse event reports

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

• MalfunctionApr 17, 2025Crack; Crack

  AS REPORTED, THE DISTAL TIP OF A 6F 100CM JUDKINS RIGHT (JR) 3.5 VISTA BRITE TIP GUIDING CATHETER WAS FOUND TO BE FRACTURED DURING PREPARATION. THE CATHETER TIP FRACTURED BUT REMAINED ATTACHED TO THE CATHETER. A NON-CORDIS GUIDING CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT AND NO SIGNS OF INFECTIOUS DISEASE. THIS WAS DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE IN WHICH ANGIOGRAPHY REVEALED A GREATER THAN 80% STENOSIS OF THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE VESSEL CHARACTERISTICS AT THE TARGET SITE INCLUDED BIFURCATION, MILD CALCIFICATION, AND MILD TORTUOSITY. THE OPERATOR HAD BEEN TRAINED. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTION FOR USE (IFU). THE CATHETER DID NOT BECOME ENTRAPPED AT ANY POINT IN THE PROCEDURE AS THE DEFECT WAS FOUND DURING PREPARATION. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21854822 ↗

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