CORDIS 67008200Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20705032020432), received between Jan 20, 2017 and May 23, 2024 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2024

  ELDERLY FEMALE WITH HISTORY OF CORONARY ARTERY DISEASE. PROCEDURE: PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY. WHEN THE CATHETER WAS REMOVED FROM THE PACKAGE, IT WAS NOTICED TO BE BENT. UNABLE TO COMPLETE PROCEDURE AND NEW ONE OBTAINED. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR CATHETER, PERCUTANEOUS, CORDIS (PER SITE REPORTER), WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19380447 ↗
• MalfunctionSep 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE TIP END OF A VISTA BRITE TIP 6F .070 JUDKINS RIGHT 4 100CM GUIDING CATHETER WAS FOUND TO BE FRACTURED. THE RADIOPAQUE DISTAL TIP WAS SEPARATED. IMMEDIATELY UPON THE REMOVAL OF THE CATHETER, IT WAS NOTICED THAT THE ¿BRAIDLESS SEGMENT¿ OF THE TIP END WAS MISSING. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS NOT USED IN THE PATIENT. THE MID RIGHT CORONARY ARTERY (RCA) WAS THE TARGET LESION. THE LESION WAS NOT CALCIFIED, HAD NO TORTUOSITY AND NO ANGULATION. THE VESSEL HAD 75% STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS NOT RESTERILIZED. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE OR DURING PREP. THE DEVICE DID NOT SEPARATE INSIDE THE PATIENT. THE STATUS OF THE PATIENT IS ¿NORMAL¿. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. THERE WAS NO DEVICE KINK IN THE AREA OF SEPARATION. THERE WAS NO RESISTANCE MET WHILE WITHDRAWING THE DEVICE. THE SEPARATION WAS FOUND BEFORE INSERTING INTO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17755427 ↗
• MalfunctionAug 28, 2023Crack; Crack

  AS REPORTED, THE HUB OF A 6F .070 JR 4 100 CM VISTA BRITE TIP GUIDING CATHETER WAS CRACKED. THIS WAS NOTICED WHEN IT WAS REMOVED FROM THE PACKAGE. THE PRODUCT WAS NOT USED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED PER LABELING. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, NOT ANSWERED, OR NOT APPLICABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17630438 ↗
• MalfunctionMay 3, 2023Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE TIP OF THE 6F VISTA BRITE TIP 0.70 JUDKINS RIGHT (JR) GUIDING CATHETER WAS FOUND FRAYED/SPLIT/TORN WHEN THE OPERATOR REMOVED THE PRODUCT FROM THE PACKAGE BEFORE A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. THE THE PRODUCT DID NOT ENTER THE BODY. THERE WAS NO REPORTED PATIENT INJURY. PRIOR TO OPENING THE PACKAGING THERE WAS NO DEVICE DAMAGE NOTICED. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. NEITHER THE PRODUCT NOR ANY OF THE OTHER DEVICES USED WITH IT HAD BEEN RE-STERILIZED. THE PRODUCT CANNOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860574 ↗
• MalfunctionAug 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 6F .070 JUDKINS RIGHT 4 VISTA BRITE TIP CATHETER COULD NOT CROSS THE BLOOD VESSEL AND WAS CUT OFF DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15275676 ↗
• InjuryAug 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE TIP OF A 6F .070¿ JUDKIN¿S RIGHT (JR) 4 100CM VISTA BRITE TIP GUIDING CATHETER SOMEHOW BECOME DETACHED FROM THE MAIN BODY OF THE CATHETER BUT WAS SUCCESSFULLY RECEIVED FROM THE PATIENT¿S VESSEL. REMOVAL WAS ACHIEVED BY INFLATING A 4MM NON CORDIS BALLOON WITHIN THE LOOSE SEGMENT OF THE GUIDE TIP AND DRAGGING IT BACK TO RECOVER INTO THE SHEATH. THE 6F NON CORDIS SHEATH WAS SWAPPED OUT OVER A 0.035" NON CORDIS GUIDEWIRE AND UPSIZED TO AN 8F NON CORDIS SHEATH. THE SEPARATED SEGMENT WAS THEN WIRED THROUGH AND SNARED WITH A NON CORDIS SNARE THROUGH THE SHEATH. THE EVENT CAUSED AN UNSPECIFIED CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE PROCEDURE. THE INTENDED PROCEDURE WAS A PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE RIGHT CORONARY ARTERY (RCA). THE LESION HAD MILD CALCIFICATION, NO TORTUOSITY, MILD ANGULATION. THERE WAS 99% STENOSIS IN THE MID RCA AND 50% STENOSIS IN THE PROXIMAL RCA. THE LESION WAS NOT A CTO. THE DEVICE WAS NOT RESTERILIZED. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THE DEVICE WAS NOT INSERTED THROUGH A STOPCOCK INSTEAD OF A HEMOSTATIC VALVE. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, OR NOT APP

  Patient problems: Foreign Body In Patient

  MAUDE report 12382619 ↗
• MalfunctionDec 24, 2019Leak/Splash; Leak/Splash

  AS REPORTED, THE 6F .070 JUDKINS RIGHT (JR) 4 100CM VISTABRITE TIP GUIDING CATHETER (GC) WAS BROKEN. IT WAS FOUND THAT THE CONNECT PART OF CATHETER WAS LEAKING DURING PREP. THERE WAS NO REPORTED PATIENT INJURY. THE PACKAGING REMAINED INTACT. THE PRODUCT WAS STORED IN CATH LAB ACCORDING TO INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE. THE DEVICE WAS PULLED FROM THE PACKAGING BY THE HUB AND NO ANOMALIES WERE NOTED AT THIS TIME. THE DEVICE WAS PREPPED FOLLOWING (IFU). THERE WAS NO DIFFICULTY ENCOUNTERED FLUSHING THE STENT DELIVERY SYSTEMS (SDS). A NON-CORDIS INDEFLATOR DEVICE WAS USED. THERE WAS NO DIFFICULTY ENCOUNTERED CONNECTING THE HUB TO THE INDEFLATOR DEVICE. THERE WERE NO ANOMALIES NOTED DURING THE TIME THE DEVICE WAS PREPPED. THE DEVICE WAS NOT USED IN THE PATIENT. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9516103 ↗
• InjuryJan 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE USE OF A 6F VISTA BRITE GUIDING CATHETER, IT WAS REPORTED THAT THE PATIENT LIFT HER ARM AND ALL THE MATERIAL CAME OUT. NEUROLOGICAL SYMPTOMS APPEARED AND A CT SCAN WAS PERFORMED. THE PATIENT WAS TRANSFERRED TO THE NEUROLOGY DEPARTMENT AT THE (B)(6) WHERE THEY TOOK OUT DEBRIS FROM THE NEUROVASCULAR SYSTEM. A PATIENT PRESENT AT THE EMERGENCY AND REQUIRED AN ANGIOGRAPHY. THE CASE WAS PERFORMED NORMALLY VIA RADIAL ACCESS.

  Patient problems: Injury

  MAUDE report 6267542 ↗

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