VISTA BRITE TIP 67005400Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 20705032020166), received between Apr 10, 2018 and Sep 1, 2023 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Crack” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2023Crack; Crack

  AS REPORTED, A 6F .070 XB 3.5 100CM VISTA BRITE TIP WAS FOUND WITH A ¿COMPRESSION FRACTURE¿ IN THE DISTAL FIRST BEND WHEN THE PACKAGING WAS OPENED. THE CATHETER WAS REPLACED AND THE PROCEDURE COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED IN AN INTERVENTIONAL PROCEDURE FOR THE LEFT CORONARY ARTERY (LCA). THE LCA HAD MILD CALCIFICATION, MILD TORTUOSITY AND A 90% STENOSIS. THE VESSEL DID NOT HAVE AN ACUTE ANGLE OR BIFURCATION. THE DEVICE WAS NOT USED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION. THE DEVICE WAS NOT INSPECTED PRIOR TO OPENING THE PACKAGE. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE USER IS TRAINED TO THE DEVICE. 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 17671470 ↗
• MalfunctionMay 30, 2023Crack; Crack

  AS REPORTED, THERE WAS A CRACK ON THE HUB OF A 6F .070 EXTRA BACK-UP (XB) 3.5 X 100CM VISTA BRITE TIP GUIDING CATHETER. THERE WERE NO REPORTS OF PATIENT INJURY. THE STAFF HAD DISCOVERED THE DEFECT AND HAD PRESENTED IT TO THE PHYSICIAN. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17022178 ↗
• MalfunctionMay 10, 2023Crack; Crack

  AS REPORTED, THE BRITE TIP/DISTAL TIP OF A 6F VISTA BRITE TIP XB 3.5 GUIDING CATHETER WAS FOUND FRACTURED. THE DEVICE DID NOT FRACTURE INTO TWO OR MORE PIECES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT UNKNOWN GUIDING CATHETER. THIS EVENT HAD NO EFFECT ON THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS PULLED FROM THE PACKAGING BY THE HUB. THE DEVICE WAS NOT TORQUED OR ¿STEERED¿ BY THE HUB. THE PATIENT HAS A PREVIOUS HISTORY OF CORONARY ARTERY DISEASE WHO WAS ADMITTED WITH ANTERIOR HEART PAIN. THE TARGET SITE WAS MODERATELY CALCIFIED AND WITH MILD TORTUOSITY. THE STENOSIS PERCENTAGE WAS 80%. THERE WAS NO ACUTE ANGLE OR BIFURCATING. THE ACCESS SITE DID NOT HAVE CALCIUM OR TORTUOSITY. THE ACCESS SITE DID NOT HAVE STENOSIS, ACUTE ANGLE, OR BIFURCATION. AN UNKNOWN CORDIS SHEATH WAS USED. THE ANGIOGRAPHY REVEALED MORE THAN 80% STENOSIS OF THE ANTERIOR DESCENDING BRANCH OF THE LEFT CORONARY REQUIRING A PERCUTANEOUS CORONARY INTERVENTION (PCI) AND A CONTRALATERAL APPROACH WAS NOT USED. THE OPERATOR HAD BEEN TRAINED TO USE OUR XB 3.5 GUIDING CATHETER. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, NOT ANSWERED, OR NOT APPLICABLE. THE DEVICE WILL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16903309 ↗
• MalfunctionAug 25, 2022Manufacturing, Packaging or Shipping Problem; Material Deformation

  EARLY 80¿S FEMALE WITH HISTORY OF CORONARY ARTERY DISEASE AND RECENT CHEST PAIN. PROCEDURE: BALLOON ANGIOPLASTY AND STENT PLACEMENT. THE CORDIS CATHETER WAS KINKED (VISIBLE IN PACKAGE) AND NOT USED ON PATIENT. MANUFACTURER RESPONSE FOR CATHETER, PERCUTANEOUS, VISTA BRITE TIP (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: Chest Pain

  MAUDE report 15292876 ↗
• MalfunctionJul 25, 2022Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, SOME BURRS WERE FOUND AT THE HEAD END OF A 6F .070 XB 3.5 100CM INFINITY DIAGNOSTIC CATHETER. NO PATIENT INJURY WAS REPORTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15098936 ↗
• MalfunctionMar 31, 2022Fracture; Fracture

  AS REPORTED, DURING A CORONARY ANGIOPLASTY A BRITE TIP GUIDING CATHETER (XB 3.5 6 FR) WAS REQUESTED BY THE HEMODYNAMICIST. AT THE TIME OF UNCOVERING IT WAS OBSERVED THAT THE DISTAL PORTION OF THE CATHETER WAS FRACTURED (FOLDED). THE DEVICE WAS NOT USED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS PROPERLY STORED AND OPENED IN STERILE FIELD. ANOTHER CATHETER WAS REQUESTED FOR THE PROCEDURE. THERE WERE NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13971291 ↗
• MalfunctionSep 10, 2021Deformation Due to Compressive Stress

  PATIENT WITH HISTORY OF HYPERTENSION AND CORONARY ARTERY DISEASE WAS PRESENTED WITH NEW ONSET OF CHEST PAIN. PATIENT WAS ADMITTED TO THE CARDIAC CATHETERIZATION LAB FOR A STENT PLACEMENT AND ANGIOPLASTY. WHEN EXAMINING THE CORDIS VISTA BRITE TIP® GUIDING CATHETER, THERE WAS A KINK IN THE CURVE OF THE GUIDE. PRODUCT NOT USED ON A PATIENT.

  Patient problems: Chest Pain

  MAUDE report 12452533 ↗
• MalfunctionAug 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, WHEN USING 6F .070 3.5 100CM VISTA BRITE TIP EXTRA BACK-UP (XB) GUIDING CATHETER PRESENTED BREAKAGE IN TWO PARTS. PATIENT HAD A MEDICAL HISTORY OF HEART DISEASE. THE DEVICE WAS NOT USED IN THE PATIENT. THE DEVICE DID NOT SEPARATE INSIDE THE PATIENT. THE DEVICE WAS NOT RESTERILIZED. TWO BREAKS WERE OBSERVED IN THE PRODUCT BEFORE USE. ABNORMALITIES WERE NOTED WHEN REMOVED FROM THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12280352 ↗
• MalfunctionJul 8, 2021Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE HEAD-END OF 6F .070 3.5 100CM VISTA BRITE TIP EXTRA BACK-UP (XB) GUIDING CATHETER WAS FRAYED/SPLIT/TORN. THEREFORE, THE DEVICE WAS REPLACED WITH ANOTHER VISTA BRITE TIP CATHETER TO COMPLETE THE OPERATION. THIS EVENT HAD NO EFFECT ON THE PATIENT AND THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT HAD MORE THAN 80% STENOSIS OF RIGHT CORONARY ARTERY AND PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS NEEDED. THE DEVICE WAS STORED IN THE LAB ACCORDING TO THE IFU FOR 15 DAYS. THE DEVICE WAS STORED AND HANDLED PER THE IFU. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12136397 ↗
• MalfunctionJan 8, 2021Material Twisted/Bent

  ELDERLY MALE WITH NEW ONSET OF CHEST PAIN, NAUSEA AND SHORTNESS OF BREATH. WHILE HAVING A DIAGNOSTIC CATH AND STENT REPLACEMENT, THE CORDIS XB 3.5 GUIDE HAD A KINK WHEN PULLED OUT OF THE PACKAGING. PRODUCT NOT USED ON PATIENT, NO KNOWN HARM.

  Patient problems: Chest Pain; Dyspnea; Nausea

  MAUDE report 11138948 ↗
• MalfunctionDec 22, 2020Material Deformation

  MIDDLE-AGED MALE PRESENTED TO EMERGENCY DEPARTMENT WITH SUDDEN ONSET OF SUBSTERNAL CHEST PAIN. HAVING A DIAGNOSTIC HEART CATH AND WHEN THE CATHETER PACKAGE WAS OPENED, THE CATHETER HAD AN OBVIOUS KINK. CATHETER NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11055210 ↗
• MalfunctionNov 17, 2020Break

  MIDDLE AGED MALE WITH RECENT CPR IN EMERGENCY DEPT AND URGENT CATH. WHEN THE PACKAGE WAS OPENED, THE DEVICE WAS SMASHED FLAT IN A LARGE AREA, MIDWAY IN THE TUBING. PRODUCT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10851014 ↗
• MalfunctionNov 13, 2020Material Twisted/Bent

  ELDERLY FEMALE WITH HISTORY OF CORONARY ARTERY DISEASE. WHILE HAVING A DIAGNOSTIC CATH, THE VISTA BRITE TIP CAME OUT OF THE PACKAGE KINKED. PRODUCT NOT USED, NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10835717 ↗
• MalfunctionNov 11, 2019Crack; Crack

  AS REPORTED BY THE PHYSICIAN, THE 6F .070 3.5 100CM VISTA BRITE TIP GUIDING CATHETER (GC) WAS FRACTURED OUT OF THE BOX WHEN IT WAS PASSED TO THE TABLE. ANOTHER CATHETER WAS THEREFORE USED, AND THE PROCEDURE WAS PERFORMED. THE PATIENT CAME OUT IN PERFECT CONDITION. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AS PER THE LABELING AND WAS PREPPED AS PER INSTRUCTION OF USE (IFU). THERE WAS NO VISIBLE DAMAGED NOTED TO THE DEVICE PRIOR TO OPENING THE PACKAGING. THERE WAS AN UNUSUAL FORCED USED. THERE WERE NO IMAGES AVAILABLE FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9304119 ↗
• MalfunctionNov 4, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  AS REPORTED, THE 6F .070 X 3.5 X 100 CM VISTA BRITE TIP GUIDING CATHETER (GC) EXTRA BACK-UP (XB) WAS FOUND OUT BY THE PHYSICIAN THAT THE CATALOGUE NUMBER WAS WRONG IN THE PACKAGE. THE ACTUAL DEVICE IN THE PACKAGING WAS 7F GUIDING CATHETER (GC) INSTEAD OF 6F GUIDING CATHETER (GC). THERE WAS NO REPORTED PATIENT INJURY. THEREFORE, THE PROCEDURE WAS COMPLETED BY REPLACING ANOTHER 6F GUIDING CATHETER (GC). INITIALLY, THE ANGIOGRAPHIC EXAMINATION SHOWED THAT THE CORONARY ARTERY IS WITH STENOSIS THAT NEEDED STENT IMPLANTATION. THEN, THE EQUIPMENT WHO PREPARE THE DEVICE GAVE IT TO THE NURSE AND THEN, THE NURSE CONFIRMED THE QUANTITY AND OPENED THE PACKAGING ONE BY ONE. AS OF NOTE: ¿THE HOSPITAL HAS REPORTED THIS CASE AS AN ADVERSE EVENT¿.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9274005 ↗
• MalfunctionJun 6, 2019Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, THREE VISTA BRITE TIP GUIDING CATHETERS (ONE - 6F .070 3 DRC 100CM & TWO - 6F .070 XB 3.5 100CM) HAD HOLES IN THEM. IT WAS NOTED THAT THE GUIDES NEVER ENTERED THE PATIENT¿S BODY. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICES WERE NOT CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8675288 ↗
• MalfunctionJun 6, 2019Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, THREE VISTA BRITE TIP GUIDING CATHETERS (ONE - 6F .070 3 DRC 100CM & TWO - 6F .070 XB 3.5 100CM) HAD HOLES IN THEM. IT WAS NOTED THAT THE GUIDES NEVER ENTERED THE PATIENT¿S BODY. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICES WERE NOT CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8675277 ↗
• MalfunctionMay 28, 2019Crack; Crack

  AS REPORTED, AT THE TIME OF SURGERY WHEN OPENING THE PACKAGING OF THE 6F VISTA BRITE TIP GUIDE CATHETER (.070 XB 3.5 100CM) WAS FOUND TO BE CRACKED AND IT WAS INFORMED THAT THE PRODUCT WAS DAMAGED. THERE WAS NO REPORTED PATIENT INJURY. 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 8647031 ↗
• MalfunctionApr 13, 2019Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, THREE VISTA BRITE TIP GUIDING CATHETERS (6F .070 XB 3.5 100CM) WERE FOUND TO HAVE HOLES IN THEM. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICES WERE NOT CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS. THERE WAS NO DAMAGE NOTED TO THE PACKAGING FOR THE DEVICES. THE DEVICES WERE STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8512146 ↗
• MalfunctionApr 13, 2019Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, THREE VISTA BRITE TIP GUIDING CATHETERS (6F .070 XB 3.5 100CM) WERE FOUND TO HAVE HOLES IN THEM. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICES WERE NOT CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS. THERE WAS NO DAMAGE NOTED TO THE PACKAGING FOR THE DEVICES. THE DEVICES WERE STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8512145 ↗
• MalfunctionApr 13, 2019Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, THREE VISTA BRITE TIP GUIDING CATHETERS (6F .070 XB 3.5 100CM) WERE FOUND TO HAVE HOLES IN THEM. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICES WERE NOT CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS. THERE WAS NO DAMAGE NOTED TO THE PACKAGING FOR THE DEVICES. THE DEVICES WERE STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8512144 ↗
• MalfunctionApr 10, 2018Fracture; Fracture

  ADDITIONAL INFORMATION WAS RECEIVED AND THE VISTA BRITE TIP GUIDING CATHETER BOX WAS SEVERELY BENT AND THE DEVICE WAS FRACTURED. THERE WAS NO PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7412090 ↗

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