VISTA BRITE TIP 6700820LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032020456), received between Apr 24, 2020 and Apr 24, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Frayed” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2020Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE 6F VISTA BRITE TIP GUIDING CATHETER WAS ATTEMPTED TO BE USED FOR A PROCEDURE, HOWEVER, IT WAS CONFIRMED THAT THE DISTAL END WAS FRAYED BEFORE INSERTION. SO, IT WAS NOT USED FOR THE PROCEDURE AND WAS REPLACED WITH A NEW UNKNOWN GUIDING CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A PERCUTANEOUS CORONARY INTERVENTION (PCI) CASE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED DUE TO SUSPICIOUS INFECTIOUS DISEASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9995903 ↗

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.