VISTA BRITE TIP 67013000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032020678), received between Jun 6, 2019 and Jun 6, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (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.

• MalfunctionJun 6, 2019Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, THREE VISTA BRITE TIP GUIDING CATHETERS (ONE - 6F .070 3 DRC 100CM & TWO - 6F .070 XB 3.5 100CM) HAD HOLES IN THEM. IT WAS NOTED THAT THE GUIDES NEVER ENTERED THE PATIENT¿S BODY. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICES WERE NOT CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8675321 ↗

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