VISTA BRITE TIP 67005200Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20705032020142), received between Dec 26, 2018 and Aug 11, 2023 — classified as 6 malfunctions.

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

• MalfunctionAug 11, 2023Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE BRITE TIP OF A 6F .070 XB 3 100 CM VISTA BRITE TIP GUIDING CATHETER WAS FOUND TO BE FRAYED DURING PREP. THE DEVICE WAS NOT USED INSIDE THE PATIENT. IT WAS REPLACED WITH ANOTHER UNKNOWN GUIDING CATHETER TO COMPLETE THE PROCEDURE. THIS INCIDENT HAD NO EFFECT ON THE PATIENT. THE DEVICE WAS NOT PULLED FROM THE PACKAGING BY THE HUB. THE DEVICE WAS NOT TORQUED OR ¿STEERED¿ BY THE HUB. THE DEVICE DAMAGE WAS NOT FRAYED INTO TWO SEPARATE PIECES. THE TARGET SITE VESSEL CHARACTERISTICS WERE MILD CALCIFICATION, NO TORTUOSITY, 80% STENOSIS, NO ACUTE ANGLE AND YES BIFURCATING. THE ACCESS SITE WAS THE RADIAL ARTERY, AND THE CHARACTERISTICS WERE NO CALCIUM, TORTUOSITY, STENOSIS, ACUTE ANGLE OR BIFURCATING. ANGIOGRAPHY REVEALED MORE THAN 80% STENOSIS OF THE LEFT ANTERIOR DESCENDING CORONARY BRANCH, WHICH REQUIRED PERCUTANEOUS CORONARY INTERVENTION (PCI). A CONTRALATERAL APPROACH WAS NOT USED. THE OPERATOR HAD BEEN TRAINED. THE PATIENT HAS A HISTORY OF CORONARY ARTERY DISEASE WHO WAS ADMITTED TO THE HOSPITAL WITH ANTERIOR CARDIAC PAIN. THE PATIENT HAS NO INFECTIOUS DISEASES. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17508688 ↗
• MalfunctionMay 20, 2022Device Damaged Prior to Use; Material Deformation

  ELDERLY MALE WITH HISTORY OF ABNORMAL STRESS TEST. PROCEDURE: HEART CATH WITH PERCUTANEOUS CORONARY INTERVENTION. GUIDE PACKAGING WAS OPENED, AND SHAFT WAS KINKED. NEVER REMOVED FROM ORIGINAL PACKAGING WHICH WAS STORED ON A SHELF. NOT USED ON PATIENT. MANUFACTURER RESPONSE FOR CATHETER, PERCUTANEOUS, VISTA BRITE TIP (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14456529 ↗
• MalfunctionNov 24, 2021Therapeutic or Diagnostic Output Failure

  MID 50¿S MALE WITH RECENT FEVER, CHEST PAIN AND NON-ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION. TAKEN FOR EMERGENT HEART CATH AND PERCUTANEOUS CORONARY INTERVENTION OF LEFT ANTERIOR DESCENDING (LAD). PROBLEM WITH THE GUIDE CATH, IT COULD NOT BE TRANSDUCED; AS IF IT WERE OCCLUDED. DEVICE REMOVED AND A NEW ONE USED WITHOUT DIFFICULTY. NO KNOWN HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868424 ↗
• MalfunctionApr 6, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, THERE WAS A REDDISH CLOT LIKE SUBSTANCE IN THE LUMEN OF A 6F .070 100CM VISTA BRITE TIP EXTRA BACK-UP (XB) GUIDING CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER UNKNOWN GUIDE CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS OPENED IN STERILE FIELD. THE PROCEDURE WAS A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WITH STENT PLACEMENT OF THE PROXIMAL CIRCUMFLEX (LCX) AND MID LEFT ANTERIOR DESCENDING ARTERY (LAD) USING A RIGHT FEMORAL APPROACH. THE LCX HAD 90% STENOSIS AND THE LAD HAD 90% STENOSIS. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, OR NOT APPLICABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION. PHOTOGRAPHS WERE PROVIDED AND AVAILABLE FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617948 ↗
• MalfunctionFeb 25, 2021Difficult to Remove; Difficult to Remove

  AS REPORTED, A 6F .070¿ 100CM EXTRA BACK-UP 3 (XB3) VISTA BRITE TIP GUIDING CATHETER LINKED IN PATIENT AND GOT STUCK. VASCULAR SURGEON HAD TO INTERVENE AND THE DEVICE WAS REMOVED THE TYPE OF PROCEDURE PREFORMED WAS A CARDIAC PERCUTANEOUS CORONARY PROCEDURE. . THE ACCESS SITE WAS RADIAL. THE DEVICE WAS PREPPED PER THE INSTRUCTION FOR USE (IFU). OTHER DEVICES USED DURING THE PROCEDURE DID NOT KINK OR BEND WITH THE PRODUCT AT ANY TIME. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 11381710 ↗
• MalfunctionDec 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING PREP, IT WAS REPORTED THAT THE DISTAL OF THE ADROIT GUIDING CATHETER WAS RUPTURED (SEPARATED) AFTER IT WAS REMOVED FROM THE PACKAGING. THERE WAS NO PATIENT INJURY. ANOTHER ADROIT GUIDING CATHETER WAS USED TO COMPETE THE PROCEDURE. THE DEVICE WAS HANDLED ACCORDING TO THE INSTRUCTION FOR USE (IFU). THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE PACKAGING. THERE WERE NO DAMAGES TO THE DEVICE PACKAGING. THERE WERE NO EXCESSIVE FORCE USED BEFORE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8196284 ↗

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