VISTA BRITE TIP 77805400Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032021873), received between May 19, 2022 and May 19, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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 18, 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.

• MalfunctionMay 19, 2022Device Damaged Prior to Use

  AS REPORTED, PER FEEDBACK FROM THE (B)(6) BONDED WAREHOUSE, A BATCH OF SUSPECTED VISTA BRITE TIP GUIDING CATHETERS (GC 7F 078 XB 3.5) WAS RECEIVED WITH A LOT OF FOLDS IN THE OUTER BOX PACKAGING. IT APPEARS THAT IT MAY BE A PROBLEM WITH THE PRINTING OF THE OUTER BOX PACKAGING MATERIAL. IT CANNOT BE DETERMINED WHETHER IT WILL CAUSE THE CUSTOMER TO REJECT IT. THERE WAS NO PATIENT INVOLVEMENT AS THE PRODUCTS WERE NOT CLINICALLY USED. PER ADDITIONAL INFORMATION PROVIDED, THE DAMAGE WAS NOTED TO THE OUTER PRODUCT BOX. THE INTEGRITY OF THE STERILE POUCH WAS COMPROMISED. THE PRODUCTS ARE STILL IN THE WAREHOUSE AND NOT IN THE LAB. THE PRODUCTS HAVE NOT BEEN CLINICALLY USED AND IT IS NOT POSSIBLE TO JUDGE IF THE DAMAGE WILL HAVE ANY EFFECT TO THE PRODUCTS INSIDE THE BOX. PRODUCT PICTURES WERE PROVIDED FOR REVIEW AND REVEALED A TOTAL OF ELEVEN (11) IMAGES OF VISTA BRITE TIP BOXES WHICH APPEAR SLIGHTLY COMPRESSED. THE PRODUCTS ARE NOT BEING RETURN FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14437081 ↗

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 i