VISTA BRITE TIP 6700820ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032020442), received between Jul 12, 2025 and Mar 2, 2026 — classified as 1 injury, 1 malfunction.

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

• MalfunctionMar 2, 2026Leak/Splash

  AS REPORTED, THE 6F .070 JR4 VISTA BRITE TIP CATHETER WAS COLLAPSED/LEAKING. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24483831 ↗
• InjuryJul 12, 2025Difficult to Remove; Difficult to Remove

  AS REPORTED, DURING AN ANGIOGRAM PROCEDURE, A 6F JUDKINS RIGHT 4 (JR4) VISTA BRITE TIP GUIDING CATHETER BECAME KINKED AND THE PHYSICIAN WAS UNABLE TO REMOVE IT. IT WAS DETERMINED THAT THE PATIENT NEEDED A HIGHER LEVEL OF CARE AND WAS TRANSPORTED TO ANOTHER MEDICAL CENTER FOR ITS REMOVAL. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND NO DAMAGE WAS NOTICED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE DEVICE WAS PREPPED ACCORDING TO THE IFU, AND NO ISSUES WERE EXPERIENCED DURING PREPARATION. IT IS NOT SPECIFIED WHETHER ANOTHER VISTA BRITE TIP WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22488900 ↗

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.