VISTA BRITE TIP 670-052-00MRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705032100571), received between Nov 10, 2025 and Apr 2, 2026 — classified as 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Crack

  AS REPORTED, THE TIP OF A 6F .070-INCH EXTRA BACKUP (XB) 3 100CM VISTA BRITE TIP GUIDING CATHETER WAS MICRO-CRACKED AND NOT VISIBLE UPON OPENING THE PACKAGE. THIS RESULTED IN LOW ARTERIAL PRESSURE OBSERVED IN THE PATIENT DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24771999 ↗
• MalfunctionApr 2, 2026Crack

  AS REPORTED, THE TIP OF A 6F .070-INCH EXTRA BACKUP (XB) 3 100CM VISTA BRITE TIP GUIDING CATHETER WAS MICRO-CRACKED AND NOT VISIBLE UPON OPENING THE PACKAGE. THIS RESULTED IN LOW ARTERIAL PRESSURE OBSERVED IN THE PATIENT DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24771973 ↗
• MalfunctionNov 10, 2025Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, A 6F .070-INCH EXTRA BACKUP (XB) 3 100CM VISTA BRITE TIP GUIDING CATHETER HAD A HOLE IN IT WHEN IT WAS REMOVED FROM THE PACKAGING. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511326 ↗

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 i
• Z-0434-05 · Dec 7, 2004 · Terminated
  VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter.