VISTA BRITE TIP 6700540ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032020176), received between Jan 12, 2026 and Mar 26, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Crack

  AS REPORTED, PIECES OF THE HUBS OF A 6F INFINITI DIAGNOSTIC CATHETER AND A 6F VISTA BRITE TIP GUIDING CATHETER CONSISTENTLY BROKE OFF DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE EXACT EVENT DATE IS UNKNOWN. MULTIPLE ATTEMPTS TO OBTAIN SUPPLEMENTAL INFORMATION WERE MADE; HOWEVER, ADDITIONAL EVENT DETAILS WERE NOT PROVIDED. THE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24703719 ↗
• MalfunctionJan 12, 2026Crack

  AS REPORTED, THE LUER LOCK HUB OF A 6F .070-INCH EXTRA BACKUP (XB) 3.5 ECO PACK GUIDING CATHETER WAS DEFECTIVE OUT OF THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. THE REPORTED ISSUE INVOLVED A GUIDING CATHETER THAT DID NOT APPEAR AS EXPECTED OUT OF THE PACKAGE. THE CUSTOMER WAS UNSURE HOW TO DESCRIBE THE DAMAGE AND NOTED THEY HAD NOT PERSONALLY SEEN THE CATHETER. THE INTENDED PROCEDURE WAS A LEFT CORONARY PERCUTANEOUS CORONARY INTERVENTION (PCI). ANOTHER EXTRA BACKUP (XB) 3.5 ECO PACK GUIDING CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND THERE WAS NO DAMAGE OBSERVED PRIOR TO OPENING THE PACKAGE. THERE WERE NO ISSUES REMOVING THE DEVICE FROM THE STERILE PACKAGING, AND IT WAS PREPPED ACCORDING TO THE IFU WITHOUT DIFFICULTY. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24046659 ↗

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.