CORDIS 67000400Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20705032019887), received between Mar 16, 2020 and Mar 31, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K021593); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2022Fracture; Fracture

  AS REPORTED, DURING A MEDICAL PROCEDURE A BRITE TIP GUIDING CATHETER (6F 0.070 JL4 100CM) WAS REQUESTED BY THE HEMODYNAMICIST AT THE TIME OF UNCOVERING IT IS OBSERVED THAT THE CATHETER WAS FRACTURED (CRACKED). THE DEVICE WAS NOT USED IN THE PATIENT. ANOTHER CATHETER WAS REQUESTED FOR THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS PROPERLY STORED AND OPENED IN STERILE FIELD. THERE WERE NO COMPLICATIONS. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13972097 ↗
• MalfunctionFeb 1, 2021Deformation Due to Compressive Stress

  ELDERLY MALE WITH HISTORY OF CORONARY ARTERY DISEASE, DIABETES AND RECENT SHORTNESS OF BREATH. PROCEDURE IS STAGED PERCUTANEOUS CORONARY INTERVENTION. WHEN THE PACKAGE WAS OPEN AND DEVICE WAS INSPECTED, THERE WERE 2 KINKS IN SEPARATE AREAS OF THE TUBING. PRODUCT NOT USED, ANOTHER DEVICE WAS OBTAINED FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11257792 ↗
• MalfunctionDec 22, 2020Detachment of Device or Device Component; Material Split, Cut or Torn

  ELDERLY MALE WITH HISTORY OF CORONARY ARTERY DISEASE AND HYPERTENSION AND ACUTE EPISODE OF NAUSEA AND DIZZINESS. WHEN PERFORMING A DIAGNOSTIC HEART CATH, THERE WAS A NICK SEEN OUT OF THE HUB OF THE CATHETER. WHEN IT WAS TOUCHED, A PIECE OF THE HUB FELL OFF. CATHETER NOT USED ON PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11055192 ↗
• MalfunctionNov 17, 2020Material Twisted/Bent

  ELDERLY MALE WITH HISTORY OF CORONARY ARTERY DISEASE AND HYPERTENSION. PRESENTED FOR DIAGNOSTIC HEART CATHETERIZATION; WHEN THE JL 4 GUIDE CATHETER WAS REMOVED FROM PACKAGING, IT WAS KINKED IN 2 AREAS. PRODUCT NOT USED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10851146 ↗
• MalfunctionMay 4, 2020Peeled/Delaminated; Material Puncture/Hole; Peeled/Delaminated; Material Puncture/Hole

  DURING OPERATION, THE 6F VISTA BITE TIP GUIDING CATHETER.070 JUDKINS LEFT (JL) 4 X 100CM WAS FOUND DAMAGED. THERE WAS NO REPORTED PATIENT INJURY. THE DAMAGE WAS NOTED DURING REMOVAL FROM THE PACKAGING. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT WERE UNKNOWN. THE DEVICE WILL BE RETURNED FOR EVALUATION. PER CLINICIAN IMAGE REVIEW, TWO IMAGES WERE RECEIVED FOR ANALYSIS. IMAGE 1 IS A PICTURE OF A 6F VISTA BRITE TIP GUIDING CATHETER BOX AND INNER PACKAGE NEXT TO IT. THE DEVICE IS VISIBLE INSIDE THE INNER PACKAGE. THE DEVICE APPEARS TO HAVE BEEN USED AS THERE ARE BLOOD RESIDUES NEAR THE PROXIMAL END OF THE CATHETER AND ON THE HUB. ALTHOUGH THE IMAGE HAS POOR CLARITY, THE CATHETER BODY/SHAFT HAS A NOTABLE ANOMALY ON THE OUTER SURFACE. THE MATERIAL APPEARS TO HAVE A SHARP CUT, EXPOSING THE BRAIDWIRE/COREWIRE. THE MATERIAL AROUND THE CUT ANOMALY APPEARS STRETCHED. IMAGE 2 APPEARS TO BE A LESS MAGNIFIED VERSION OF IMAGE 1. THE BOX OF A 6F VISTA BRITE TIP GUIDING CATHETER IS PICTURED WITH THE INNER PACKAGE NEXT TO IT. THE DEVICE IS VISIBLE INSIDE THE INNER PACKAGE. THE IMAGE HAS POOR CLARITY AND THE DETAILS OF THE NOTED ANOMALY ARE NOT CLEARLY VISIBLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10022078 ↗
• InjuryMar 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  A .070 JUDKINS LEFT (JL) 4 X 100CM 6F VISTA BITE TIP CORONARY GUIDING CATHETER TWISTED IN A PATIENT DURING USE, THE OPERATOR ATTEMPTED TO "UN-TWIST" CATHETER, WHEN FAILING TO DO SO, ATTEMPTED TO PULL THE CATHETER OUT OF THE BODY; BUT THE CATHETER THEN BROKE OFF IN THE BODY. THE PATIENT TAKEN TO SURGERY TO REMOVE REMAINING CATHETER PIECE (THE TIP), SUCCESSFULLY. THE DEVICE IS AVAILABLE FOR AN ON-SITE EVALUATION ONLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9835531 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021593. One submission often covers many models, so check the product and lot details in each record.

• Z-1330-2025 · Feb 7, 2025 · Open, Classified
  Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices
• 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
• Z-0434-05 · Dec 7, 2004 · Terminated
  VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter.