VISTA BRITE TIP 67018000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032020760), received between Jan 28, 2020 and Jun 22, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2021Break

  PATIENT WITH HISTORY OF HYPERTENSION, AND RECENT CHEST PAIN POST CORONARY ARTERY BYPASS GRAFT WAS ADMITTED FOR A CARDIAC CATHETERIZATION. WHEN THE CORDIS VISTA BRITE TIP 6F LCB 100CM VASCULAR GUIDE-CATHETER WAS REMOVED FROM PACKAGING, THE TIP WAS DAMAGED. THE CORDIS VASCULAR GUIDE-CATHETER WAS NOT USED ON THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 12040592 ↗
• InjuryJan 28, 2020Difficult to Remove; Difficult to Remove

  AS REPORTED, THE 6F .070¿ VISTA BRITE TIP LEFT CORONARY BYPASS (LCB) GUIDING CATHETER (GC) WAS UNABLE TO REMOVE THRU THE SHEATH DUE TO BEING KINKED. THERE WAS NO REPORTED PATIENT INJURY. THE LEFT RADIAL 6F TERUMO 80-1060 SLENDER SHEATH AND THE LCB NEEDED TO BE PULLED OUT TOGETHER. WITH A PORTION OF THE SHEATH/GUIDE REMOVED FROM THE VESSEL, A KINK WAS NOTED IN THE LCB CATHETER. IN ORDER TO SAVE ARTERIAL ACCESS, THE GUIDE CATHETER WAS CUT DISTAL TO THE KINK. MAINTAINING POSITION CONTROL OF THE CUT LCB GUIDING CATHETER, A NEW GUIDEWIRE WAS INSERTED THROUGH IT. THE CUT LCB CATHETER WAS THEN REMOVED FROM THE BODY. A STANDARD 6F NON-CORDIS SHEATH WAS PLACED OVER THE GUIDEWIRE IN THE LEFT RADIAL AND THE CASE PROCEEDED. A SECOND LCB GUIDE CATHETER (SAME CATALOG AND SERIAL #) WAS PULLED. IT WAS NOTED TO BE KINKED AT THE SCRUB TABLE AND WAS NOT USED. THE NON-CORDIS SLENDER SHEATH WAS NOT SAVED. THERE WERE NO RADIAL ACCESS SITE COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. THE INTENDED PROCEDURE/TARGET LESION WAS ANGIOGRAPHY OF BYPASS GRAFT TO LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS NOT CALCIFIED. THERE WAS LITTLE TO MODERATE VESSEL TORTUOSITY. THERE WAS NO VESSE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9636548 ↗

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