VISTA BRITE TIP 67019055Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032020845), received between Oct 24, 2022 and Oct 24, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 6F .070 INTERNAL MAMMARY (IM) 55CM VISTA BRITE TIP CATHETER BECAME KINKED INSIDE THE RIGHT ILIAC ARTERY. THE RIGHT ILIAC ARTERY WAS QUITE TORTUOUS, AND THE PHYSICIAN WAS HAVING A DIFFICULT TIME CANNULATING THE RENAL ARTERY. AFTER MANIPULATION OF THE VISTA BRITE TIP CATHETER, THE CATHETER SNAPPED OFF INSIDE THE ILIAC ARTERY. AT THIS TIME, THE PHYSICIAN ELECTED TO USE AN 3.2F 4MMX8MM NON-CORDIS, TO ATTEMPT TO REMOVE THE CATHETER. THE CATHETER WAS SNARED, THEN PULLED BACK INTO THE 6FR 10 CM NON-CORDIS SHEATH. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE SNAPPED OFF GUIDE PIECE ALONG WITH THE 6FR 10 CM NON-CORDIS SHEATH FROM THE FEMORAL ARTERY. THE CATHETER WAS PULLED BACK INTO THE COMMON FEMORAL ARTERY BUT WAS UNABLE TO BE REMOVED FROM THE BODY. AT THIS TIME, THE PHYSICIAN AND A VASCULAR SURGEON DECIDED IT WOULD BE BEST TO REMOVE THE CATHETER SURGICALLY. THE PATIENT WAS THEN TRANSFERRED TO SURGERY AND THE CATHETER WAS REMOVED WITHOUT INCIDENT. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH NO FURTHER COMPLICATIONS. THERE WAS NO REPORTED PATIENT INJURY. THE PHYSICIAN WAS PERFORMING A DIAGNOSTIC ANGIOGRAM TO ASSESS THE PATIENT'S RENAL ARTERIES. THE PHYSICIAN WAS USING THE VIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15662929 ↗

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