VISTA BRITE TIP 67008400Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032020494), received between Nov 28, 2016 and Nov 28, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment Of Device Component” (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.

• InjuryNov 28, 2016Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE LAST 10CM OF THE VISTA BRITE GUIDING CATHETER BROKE COMPLETELY OFF AND IS FLOATING IN THE AORTA. THE PHYSICIAN MANAGED TO SUCCESSFULLY RETRIEVE THE DISTAL TIP WITH A COOK SNARE. ANOTHER GUIDE CATHETER WAS USED AND STENTED OF THE RIGHT CORONARY WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT INJURIES. THE PHYSICIAN ADVANCED THE GUIDING CATHETER IN THE AORTA. WHEN HE ADVANCED IT OVER THE AORTA ARCH (BEFORE POSITIONING AND SELECTING A CORONARY) HE TURNED (TORQUED) THE CATHETER AND FELT THAT THE CATHETER DID NOT WANT TO MOVE. WHEN HE OBSERVED THE SCREEN HE SAW THAT THE LAST 10 CM OF THE CATHETER BROKE COMPLETELY OFF. ALL PARTS WERE KEPT, THE SHAFT AND THE BROKEN OFF TIP, PLACED IN A CIDEX FOR 10 MIN AND THEN FLUSHED WITH WATER AND CIDEX. THE DEVICE IS AVAILABLE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6128557 ↗

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