VISTA BRITE TIP 67012600Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032020654), received between Nov 14, 2019 and Mar 16, 2023 — classified as 3 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K963962); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, A HAIR WAS FOUND IN THE INNER PACKAGE OF 6F .070 EXTRA BACK-UP RIGHT CA 100CM VISTA BRITE TIP GUIDING CATHETER WHEN IT WAS DELIVERED TO THE HOSPITAL. THEREFORE, MAKING IT UNUSABLE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16554762 ↗
• MalfunctionJan 20, 2020Leak/Splash; Leak/Splash

  AS REPORTED, THE CONNECTED PART OF THE 6F X .070¿ X 100CM EXTRA BACK-UP (XB) RIGHT CORONARY ARTERY (RCA) VISTA BRITE TIP GUIDING CATHETER (GC) HAD A LEAKED DURING PREP. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AS PER THE LABELING. THE DEVICE WAS NOT RESTERILIZED AND WAS PREPPED FOLLOWING INSTRUCTIONS FOR USE (IFU). THERE WERE LEAKAGE ANOMALIES NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE AND WHEN PULLED FROM THE PACKAGING BY THE HUB. OTHER ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9607919 ↗
• MalfunctionNov 14, 2019Crack; Crack

  AS REPORTED, THERE WAS EVIDENCE OF FRACTURE AT THE TIME THE PHYSICIAN PASSED THE 6F .070 XB RCA 100CM VISTA BRITE TIP GUIDING CATHETER TO THE TABLE. THEREFORE, THEY CHANGED THE DEVICE WITH ANOTHER UNKNOWN CATHETER AND THE PROCEDURE IS PERFORMED. THE PATIENT COMES OUT IN PERFECT CONDITION. THIS IS A CASE OF CARDIAC CATHETERIZATION. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED PER THE IFU. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9322922 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K963962. One submission often covers many models, so check the product and lot details in each record.

• 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