NuVent ™ 1830717SPHRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169770980), received between May 18, 2018 and Jan 16, 2024 — classified as 2 malfunctions.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 16, 2024Break; Break

  IT WAS REPORTED THAT DEVICE WAS BEING INFLATED THE INFLATER INDICATOR DID POP OUT AS NORMAL AND THEN THE BALLOON FAILED AS IT WAS DILATING THE SINUS. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. NO PATIENT IMPACT. ADDITIONAL INFORMATION STATES THAT BALLOON BROKE WHILE BEING DILATED. DIDN¿T INFLATE PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518782 ↗
• MalfunctionMay 18, 2018Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION THAT, DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, THE SPHENOID BALLOON WAS IMPRECISE. ALL OTHER INSTRUMENTS USED DURING THE PROCEDURE WERE ACCURATE. AFTER GETTING VISUAL CONFIRMATION AND CHECKING THE ACCURACY WITH A SUCTION, THE SURGEON BALLOONED THE SPHENOID SINUS. THERE WAS A REPORTED DELAY OF A FEW MINUTES. NO KNOWN IMPACT ON PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7527885 ↗