NuVent ™ 1830617FRT (UDI 00643169420441)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169420441), received between Oct 10, 2016 and Oct 10, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Imprecision” (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.

• MalfunctionOct 10, 2016Imprecision; Imprecision

  A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING AN EAR, NOSE, AND THROAT PROCEDURE, THE NAVIGATION SYSTEM WAS INACCURATE. IT WAS REPORTED THAT THE INACCURACY WAS NOTED AFTER REGISTRATION, WHILE NAVIGATING A BALLOON. ALL OTHER INSTRUMENTS WERE REPORTEDLY ACCURATELY NAVIGATING. THE DIRECTION AND MAGNITUDE OF THE INACCURACY WAS NOT PROVIDED. THE SURGEON ELECTED TO COMPLETE THE PROCEDURE WITH THE INACCURACY, AND IT WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT IMPACTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6015415 ↗