Flyte 0408850000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613154891207), received between Jul 27, 2020 and Oct 28, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD MATERIAL THAT WAS SPLIT, CUT, OR TORN DUE TO EXTERNAL OR INTERNAL FORCES. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10748507 ↗
• MalfunctionJul 27, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE HAD MATERIAL THAT WAS SPLIT, CUT, OR TORN DUE TO EXTERNAL OR INTERNAL FORCES. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10329711 ↗