VISTA BRITE TIP 77803400Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032021699), received between Jun 23, 2020 and Jun 23, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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 23, 2020Crack; Crack

  AS REPORTED, THE HEAD-END OF 7F .078" .75 JAL VISTA BRITETIP GUIDING CATHETER WAS FOUND FRACTURED DURING USE. THEREFORE, THE DEVICE WAS REPLACED WITH ANOTHER UNKNOWN GUIDE CATHETER TO COMPLETE THE OPERATION. IT HAS NO EFFECT TO THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT HAD HISTORY OF CORONARY HEART DISEASE AND HAD BEEN IMPLANTED WITH UNKNOWN STENT BEFORE. THE PATIENT HAD EXPERIENCED PAIN CAUSING HIS RE-HOSPITALIZATION. FOLLOWING A RADIOGRAPHIC EXAMINATION, IT WAS FOUND THAT THE LEFT CORONARY ARTERY (LCA) HAS 80% STENOSIS THAT SUGGESTED A NEED TO BE RE-TREATED WITH PERCUTANEOUS CORONARY INTERVENTION (PCI). THE DEVICE WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO VISIBLE DAMAGE NOTED TO THE DEVICE PRIOR TO OPENING THE PACKAGE. THE LESION WAS MODERATELY CALCIFIED, WITH NO VESSEL TORTUOSITY. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE ACCESS SITE WAS THE RADIAL ARTERY. THERE WAS NO EXCESS FORCE USED AT ANY TIME DURING THE PROCEDURE. THE HEAD-END WAS KINKED. THE DEVICE WAS REMOVED IN ONE PIECE. ANOTHER VISTA BRITE TIP GUIDING CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WILL BE RETURNED FOR EVALUATIO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10184335 ↗

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