VISTA BRITE TIP 77800400Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032021521), 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 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 3, 2023Crack; Crack

  AS REPORTED, THE 7F VISTA BRITE TIP JUDKINS LEFT 4 GUIDING CATHETER FRACTURED DURING USE IN A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED, HANDLED, INSPECTED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED WHEN THE PRODUCT WAS REMOVED FROM THE PACKAGING. THE TIP 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 17455376 ↗

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 into