NuVent™ 18INFKIT (UDI 00763000745080)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000745080), received between Apr 16, 2026 and Apr 16, 2026 — classified as 1 malfunction.

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

• MalfunctionApr 16, 2026Break

  IT WAS REPORTED THAT INTRA-OP DURING TYMPANOPLASTY WITH EUSTACHIAN TUBE DILATION, THE PLUNGER OF THE INFLATOR KIT CAME OUT WHILE THE NURSE WAS TRYING TO FILL IT WITH WATER. WHILE THE BALLOON DILATOR HAD A SMALL LEAK, AND WASN¿T ABLE TO BE FULLY DILATED. THE LEAKAGE TEST WAS PERFORMED BEFORE USE ON PATIENT, THE LEAK WAS ALREADY EVIDENT. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24893931 ↗