VISTA BRITE TIP 67008100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032020425), received between Jul 6, 2021 and Jul 31, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Crack” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2023Crack; Difficult to Remove; Crack; Difficult to Remove

  AS REPORTED, DURING AN EMERGENT CARDIAC CATHETERIZATION TO TREAT A PATIENT FOR HEART ATTACK, A 6F 100CM JUDKINS RIGHT (JR) 3.5 2 SIDE-HOLE VISTA BRITE TIP GUIDING CATHETER BECAME COILED INSIDE OF THE PATIENT¿S ARTERY WHILE ATTEMPTING TO TORQUE THE DEVICE. THIS MADE IT DIFFICULT TO MANEUVER THE CATHETER. RESISTANCE WAS EXPERIENCED WHILE WITHDRAWING THE DEVICE AND THE DISTAL CATHETER WAS FRACTURED UPON REMOVAL. AN UNKNOWN 6F CATHETER SHEATH INTRODUCER (CSI), WHICH WAS INSERTED FROM THE RIGHT FEMORAL ARTERY, WAS THEN EXCHANGED FOR A 7F 45CM BRITE TIP CSI WHICH WAS ABLE TO ADLE TO ADVANCE TORTUOUSLY. A NEW 6F 100CM JR 3.5 VISTA BRITE TIP GUIDING CATHETER WAS THEN INSERTED; HOWEVER, THE SAME ISSUE OCCURRED WHERE THE DEVICE WAS COILED UPON TORQUING, THERE WAS DIFFICULTY REMOVING THE DEVICE, AND THE DISTAL CATHETER WAS FRACTURED. AS A RESULT, THE ACCESS SITE WAS SWITCHED TO THE LEFT FEMORAL ARTERY AND THE 7F 45CM BRITE TIP CSI WAS INSERTED. THE RIGHT CORONARY ARTERY (RCA) WAS CANNULATED, AND A NON-CORDIS .014 GUIDEWIRE WAS ADVANCED TO THE DISTAL PORTION OF THE VESSEL. A PROXIMAL SEGMENT LESION WAS CONFIRMED AND A THROMBECTOMY WAS PERFORMED WITH THE CLOTS DESCRIBED AS ¿ABUNDANT¿. A NON-COR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17424078 ↗
• MalfunctionJul 31, 2023Crack; Difficult to Remove; Crack; Difficult to Remove

  AS REPORTED, DURING AN EMERGENT CARDIAC CATHETERIZATION TO TREAT A PATIENT FOR HEART ATTACK, A 6F 100CM JUDKINS RIGHT (JR) 3.5 2 SIDE-HOLE VISTA BRITE TIP GUIDING CATHETER BECAME COILED INSIDE OF THE PATIENT¿S ARTERY WHILE ATTEMPTING TO TORQUE THE DEVICE. THIS MADE IT DIFFICULT TO MANEUVER THE CATHETER. RESISTANCE WAS EXPERIENCED WHILE WITHDRAWING THE DEVICE AND THE DISTAL CATHETER WAS FRACTURED UPON REMOVAL. AN UNKNOWN 6F CATHETER SHEATH INTRODUCER (CSI), WHICH WAS INSERTED FROM THE RIGHT FEMORAL ARTERY, WAS THEN EXCHANGED FOR A 7F 45CM BRITE TIP CSI WHICH WAS ABLE TO ADLE TO ADVANCE TORTUOUSLY. A NEW 6F 100CM JR 3.5 VISTA BRITE TIP GUIDING CATHETER WAS THEN INSERTED; HOWEVER, THE SAME ISSUE OCCURRED WHERE THE DEVICE WAS COILED UPON TORQUING, THERE WAS DIFFICULTY REMOVING THE DEVICE, AND THE DISTAL CATHETER WAS FRACTURED. AS A RESULT, THE ACCESS SITE WAS SWITCHED TO THE LEFT FEMORAL ARTERY AND THE 7F 45CM BRITE TIP CSI WAS INSERTED. THE RIGHT CORONARY ARTERY (RCA) WAS CANNULATED, AND A NON-CORDIS .014 GUIDEWIRE WAS ADVANCED TO THE DISTAL PORTION OF THE VESSEL. A PROXIMAL SEGMENT LESION WAS CONFIRMED AND A THROMBECTOMY WAS PERFORMED WITH THE CLOTS DESCRIBED AS ¿ABUNDANT¿. A NON-COR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17424005 ↗
• MalfunctionJul 6, 2021Crack; Crack

  AS REPORTED, THE 6F .070 100CM JUDKINS RIGHT (JR3.5) 2 SIDE-HOLES (SH) VISTA BRITE TIP GUIDING CATHETER (GC) WAS OPENED AND WHEN IT WAS PLACED ON THE TABLE, IT WAS OBSERVED FRACTURED. SO, IT NOT WAS NOT USED, AND IT WAS DECIDED TO USE ANOTHER DEVICE (UNKNOWN). THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS A RIGHT CORONARY ANGIOPLASTY. THERE WAS NO DIFFICULTY REMOVING THE PRODUCTS FROM THE PACKAGE. ANOTHER VISTA BRITE TIP GUIDE CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12119776 ↗

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