CORDIS 67003400Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032020036), received between Jun 15, 2023 and Jun 15, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 15, 2023Material Twisted/Bent

  ELDERLY FEMALE WITH HISTORY OF TYPE 1 DB (DIABETES), CAD (CORONARY ARTERY DISEASE) AND RECENT SOB (SHORTNESS OF BREATH) AND EDEMA. PROCEDURE: DIAGNOSTIC HEART CATH AND PCI (PERCUTANEOUS CORONARY INTERVENTION). 2 KINKS WERE VISUALIZED IN THE CORDIS, VISTA BRITETIP CATHETER. NOT USED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17134811 ↗

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