NuVent ™ 1830617FRT (UDI 00643169770942)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169770942), received between Aug 9, 2018 and Dec 27, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission 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. 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.

• MalfunctionDec 27, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM THAT WAS USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE BREAKOUT BOX LIGHT WAS YELLOW TO START THE CASE SO THE SITE UNPLUGGED AND RE-PLUGGED IT AND IT WORKED. WHEN THEY ATTEMPTED TO USE THE 98 DEGREE BALLOON, THE LIGHT WAS AGAIN YELLOW SO THEY TRIED OTHER PORTS BUT IT STILL NEVER CHANGED TO GREEN. THEY THEN UNPLUGGED THE BREAKOUT BOX AND PLUGGED IT BACK IN. THE BALLOON STAYED YELLOW BUT EVERYTHING ELSE WAS GREEN. IT WOULD NOT WORK AT ALL AND IT DIDN¿T RECOGNIZE ANYTHING EVEN THOUGH THE LIGHT WAS GREEN. THE SITE THEN TURNED OFF THE SYSTEM, UNPLUGGED THE BREAKOUT BOX AND PLUGGED IT BACK IN THEN TURNED THE SYSTEM BACK ON. HOWEVER, THE BALLOON WAS STILL YELLOW THOUGH EVERYTHING ELSE WAS GREEN. THE SYSTEM WORKED, SO THEY OPENED A NEW BALLOON AND THEN THE LIGHT TURNED GREEN. THIS RESOLVED THE ISSUE. THERE WAS NO KNOWN IMPACT ON PATIENT OUTCOME. THE ISSUE RESULTED IN LESS THAN ONE HOUR PROCEDURE DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9525723 ↗
• MalfunctionAug 9, 2018Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION INTRA-OPERATIVELY DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). THE ENT REP CALLED IN WITH A SURGEON ON SITE DURING THE PROCEDURE. IT WAS REPORTED THAT INITIALLY THE FRONTAL BALLOON WAS NOT RECOGNIZED BY THE SYSTEM WHEN IT WAS PLUGGED INTO THE AXIEM PORTS. THE EMITTER DETAILS VIEW SHOWED NOTHING PLUGGED INTO THE PORT. IT WAS SWAPPED FOR A DIFFERENT BALLOON AND THE SAME ISSUE OCCURRED. IT OCCURRED ON ALL PORTS OF THE SYSTEM. NO OTHER INSTRUMENTS THAT WERE PLUGGED INTO THOSE PORTS AT THE TIME HAD ANY ISSUE WITH TRACKING OR NAVIGATING. THE ISSUE EXTENDED THE SURGICAL TIME BY LESS THAN 1 HOUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7770377 ↗