NuVent ™ 1830717FRT70Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169705289), received between Aug 9, 2018 and Nov 7, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Crack” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2018Loose or Intermittent Connection; Material Separation; Failure to Unfold or Unwrap; Loose or Intermittent Connection; Material Separation; Failure to Unfold or Unwrap

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE BALLOON HAD A LOOSE METAL CUFF, THE BALLOON SEEK ER DID NOT INFLATE AND THAT THE METAL CUFF HAD BROKEN OFF AND SLID FORWARD DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY PROCEDURE. A SECOND BALLOON WAS OPENED AND THE PROCEDURE WAS COMPLETED WITH NO ISSUES. THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8048091 ↗
• InjuryAug 9, 2018Crack; Material Puncture/Hole; Gas/Air Leak; Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING A NAVIGATED SINUS PROCEDURE THE SURGEON BALLOONED LEFT THEN RIGHT SPHENOID WITH SPHENOID BALLOON. HE THEN SWITCHED BALLOONS TO A FRONTAL BALLOON AND BALLOONED LEFT FRONTAL. WENT TO RIGHT FRONTAL TO BALLOON AND INDICATOR DID NOT ¿POP¿. TOOK BALLOON OUT, RECHARGED [PRIMED] INFLATOR, WENT BACK INTO FRONTAL, NOTICED CLEAR LIQUID AND INDICATOR STILL DID NOT POP. TOOK BALLOON OUT, EXAMINED BALLOON AND NOTICED HOLE IN BALLOON CAUSING THE LEAK. ANOTHER FRONTAL BALLOON WAS LOCATED AND CONNECTED TO THE INFLATOR; AND THEN THE INFLATOR WAS CHARGED [PRIMED]. WENT BACK TO RIGHT FRONTAL, PUSHED DOWN PLUNGER AND INDICATOR DID NOT POP. NOTICED AIR IN THE LINE. PULLED BALLOON BACK OUT AND RECHARGED [PRIMED] THE INFLATOR MAKING SURE THERE WAS NO AIR IN LINE. WENT BACK INTO FRONTAL AND SUCCESSFULLY BALLOONED. THE SURGEON THEN NOTICED A CLEAR LIQUID ON THE RIGHT SIDE OF THE PATIENT'S NOSE THAT WAS FOUND TO BE A CSF LEAK, WHICH WAS CONFIRMED WITH A CT SCAN; "THE CT REVEALED THERE WAS A SMALL CRACK ON THE POSTERIOR SIDE OF THE FRONTAL SINUS". WHEN THE CSF LEAK OCCURRED IS NOT KNOWN; HOWEVER, THEY CONFIRMED THAT THERE WERE NO ISSUES WITH THE NAVIGATION. THE CSF LEAK WAS TREATED AND AT THIS TIME THE

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 7766932 ↗