VISTA BRITE TIP 4037553RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032000908), received between Oct 14, 2016 and Oct 14, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

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.

• MalfunctionOct 14, 2016Detachment Of Device Component

  IT WAS REPORTED THAT THE HEAD OF A 7FVISTA BRITE TIP INTRODUCER GUIDING CATHETERS DETACHED IN THE PATIENT WHEN THE DEVICE WAS REMOVED. THE PHYSICIAN REMOVED THE DEVICE SAFELY FROM THE PATIENT AND THE PROCEDURE WAS CONTINUED. THERE WERE NO PATIENT INJURIES. A 20F NON CORDIS SHEATH INTRODUCER WAS USED AND THE PROCEDURE WAS FOR PLACING A STENT GRAFT IN THE ILIAC ARTERY. ADDITIONAL INFORMATION WAS RECEIVED AND THERE WERE NO KINKS OBSERVED ON THE DEVICE. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE OR DURING PREP. RESISTANCE WAS NOT MET WHILE ADVANCING THE DEVICE OR WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE OR WHILE WITHDRAWING THE DEVICE. EXCESSIVE TORQUING WAS NOT REQUIRED. THE DEVICE DID NOT KINK IN THE AREA OF SEPARATION. THE DEVICE SEPARATED NEXT TO THE HUB. THE SEGMENT WAS RETRIEVED BY HAND, THE END OF THE DEVICE WAS JUST OUTSIDE OF THE SHEATH. A REPLACEMENT CATHETER WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Information

  MAUDE report 6031504 ↗