VISTA BRITE TIP 67027090Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032020968), received between Jul 12, 2019 and Jul 12, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Frayed” (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.

• MalfunctionJul 12, 2019Material Frayed; Material Frayed

  AS REPORTED, A 6F .070 MPA-1 90CM VISTA BRITE TIP GUIDING CATHETER WAS BEING USED FOR A CHRONIC TOTAL OCCLUSION (CTO), HOWEVER, BEFORE REACHING THE LESION IT COULD NOT ADVANCE ANYMORE AND THE DISTAL END BECAME FRAYED. THERE WAS NO REPORTED PATIENT INJURY. THE DOCTOR COMMENTED THAT THE ISSUE MIGHT HAVE OCCURRED WITH THE LESION HAVING HEAVY CALCIFICATION AND THE DEVICE WAS PUSHED STRONGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8785273 ↗

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