LEGION 71423035Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010506344), received between Jun 2, 2021 and Jun 2, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 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.

• MalfunctionJun 2, 2021Inadequacy of Device Shape and/or Size; Device Markings/Labelling Problem; Inadequacy of Device Shape and/or Size; Device Markings/Labelling Problem

  IT WAS REPORTED THAT, DURING SURGERY, THE SC HM ST 5-6 10MM LTMD RTLA WAS NOT THE SAME AS THE DESCRIPTION AND THE LABELING DUE TO ITS WRONG SIZING. THE PROCEDURE WAS COMPLETED, WITH A DELAY GREATER THAN 30 MINUTES, USING A S+N BACK-UP DEVICE. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11918389 ↗