CORDIS 67000200Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032019863), received between May 12, 2021 and Jul 8, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2022Material Puncture/Hole; Difficult to Remove; Detachment of Device or Device Component; Material Puncture/Hole; Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED, THE MIDDLE PART OF A 6F .070 JL3.5 100CM VISTA BRITE TIP GUIDING CATHETER WAS FOUND BROKEN AS THE CATHETER WAS BEING PULLED DURING THE PROCEDURE; IT HAD A PUNCTURE/CUT. THEREFORE, THE PRODUCT WAS NOT AVAILABLE. ¿BROKEN¿ IS MEANT AS THE DEVICE WAS PUNCTURE/CUT. THE CATHETER WAS REMOVED INTACT FROM THE PATIENT. THERE WAS WITHDRAWAL DIFFICULTY OF THE DEVICE THAT LED TO THE DEVICE BEING PULLED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED IN A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. THE ACCESS SITE WAS THE FEMORAL ARTERY. THERE WAS NO DIFFICULTY EXPERIENCED WHEN PREPPING THE DEVICE. THERE WAS NO CONTRALATERAL APPROACH USED. THE VESSEL AT THE TARGET SITE WAS MILDLY CALCIFIED, AND MILDLY TORTUOUS. THE VESSELS ACCESSING THE TARGET SITE WERE MILDLY CALCIFIED, AND MILDLY TORTUOUS WITH AN ACUTE ANGLE OF 30-40 DEGREES. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THE PHYSICIAN ACHIEVED CERTIFICATION ON THE USE OF THE VISTA BRITE TIP CATHETER AND HAS USED THE DEVICE SEVERAL TIMES PRIOR TO THIS PROCEDURE. THE DEVICE WAS PREPARED AND USED IN ACCORDANCE WITH IFU INSTRUCTIONS. O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14957140 ↗
• MalfunctionJun 14, 2021Material Frayed; Material Frayed

  DURING PREP, WHEN A 6F .070 JL3.5 100CM VISTA BRITE TIP GUIDING CATHETER WAS USED AND IT WAS FOUND THAT THE HEAD END WAS DAMAGED (FRAYED/SPLIT). IT WAS THEN REPLACED WITH ANOTHER GUIDE CATHETER (UNKNOWN) TO COMPLETE THE OPERATION. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT HAD A HISTORY OF CORONARY HEART DISEASE AND PERICARDIAL PAIN AND WAS ADMITTED TO THE HOSPITAL. ANGIOGRAPHIC EXAMINATION SHOWED THAT MORE THAN EIGHTY PERCENT (80%) OF THE LEFT ANTERIOR DESCENDING CORONARY ARTERY WAS STENOSIS, ALONG WITH SEVENTY PERCENT (70%) CALCIFICATION AND NEEDED PERCUTANEOUS CORONARY INTERVENTION (PCI) TREATMENT. THERE WERE NO DAMAGES NOTED TO THE DEVICE PACKAGING. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE PACKAGING. THE BRITE TIP WAS PREPPED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU). THERE WERE NO EXCESSIVE FORCE USED ANYTIME DURING THE PROCEDURE. THE DEVICE WILL BE RETURNED FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11995714 ↗
• MalfunctionMay 12, 2021Difficult to Remove; Difficult to Remove

  A 6F .070¿ 100CM JUDKIN¿S LEFT 4 (JL4) VISTA BRITE TIP GUIDING CATHETER WAS USED TO ATTEMPT ARTERY ENGAGEMENT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI); HOWEVER, BEFORE THE VISTA BRITE TIP WAS ABLE TO ENGAGE, A LARGE PORTION OF THE IT COLLAPSED AND FLATTENED. IN ADDITION, WHEN THEY ATTEMPTED TO REMOVE THE VISTA BRITE TIP IT WOULD NOT COME OUT OF THE UNKNOWN AVANTI SHEATH DUE TO THE FLATTENED PORTION. CASE WAS NOT ABLE TO BE COMPLETED AND PATIENT WAS ASKED TO COME BACK AFTER THREE DAYS TO RE-ATTEMPT PCI. THERE WAS NO REPORTED PATIENT INJURY. PHYSICIAN NOTICED THAT THERE WAS AN ISSUE WHEN THEY WERE NOT ABLE TO INJECT CONTRAST INTO THE VISTA BRITE TIP. THE VISTA BRITE TIP AND THE UNKNOWN AVANTI SHEATH HAD TO BE COMPLETELY REMOVED TOGETHER AND TOTAL ACCESS WAS LOST. THE OPERATOR WAS TRAINED TO USE THE DEVICE. THE DEVICE WAS OPENED IN A STERILE FIELD. THE DEVICE WAS STORED AND HANDLED PER THE IFU. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THERE WAS NO DAMAGE NOTED TO THE PRODUCT UPON INSPECTION PRIOR TO USE. THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11813825 ↗
• MalfunctionMay 12, 2021Device-Device Incompatibility; Device-Device Incompatibility

  AS REPORTED, THE 6F .070 100CM JUDKINS LEFT (JL 3.5) VISTA BRITE TIP GUIDING CATHETER (GC) WILL NOT WORK WITH THE NON-CORDIS EXTENSION CATHETER. THE CUSTOMER THOUGHT THE GUIDES ARE NOT THE SAME ALL THE WAY THROUGH THE LUMEN. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED PER LABELLING AND OPENED IN STERILE FIELD. THE DEVICE WAS NOT USED IN THE PATIENT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812364 ↗

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.