LeVeen™ Standard M001262310Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729120735), received between Mar 4, 2021 and Mar 4, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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.

• MalfunctionMar 4, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED FOREIGN MATERIAL WAS PRESENT ON THE DEVICE. A RADIOFREQUENCY ABLATION PROCEDURE WAS BEING PERFORMED. A 4.0CM LEVEEN STANDARD ELECTRODE WAS OPENED ON THE STERILE FIELD AND AS THE SURGEON WAS ABOUT TO USE IT HE NOTICED THAT AT THE TIP OF THE NEEDLE THERE WAS A WHITE SUBSTANCE/DEBRIS. IT WAS NOT USED ON A PATIENT AND HANDED OFF THE FIELD. THE PATIENT WAS FINE AND THE CASE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11411263 ↗