VISTA BRITE TIP 77808200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032022016), received between Jul 8, 2022 and Jul 8, 2022 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 8, 2022Crack; Crack

  AS REPORTED, A 7F .078 JUDKINS RIGHT 4 VISTA BRITE TIP CATHETER WAS CRUMPLED AND CRACKED. THE CRACK WAS NOTED DURING THE PREPARATION OF THE MATERIALS BEFORE THE USE ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNKNOWN CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE PRODUCT PACKAGING NOR TO THE PRODUCT WHEN REMOVED FROM THE PACKAGE. THE INTENDED PROCEDURE WAS A CORONARY ANGIOPLASTY. THE CATHETER WAS NOT USED INSIDE THE PATIENT. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14961066 ↗

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