NuVent™ 18INFKIT (UDI 00643169770997)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169770997), received between Dec 16, 2019 and Oct 7, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED STATING THE ISSUE HAPPENED PRIOR TO SURGERY DURING PRIMING THE DEVICE, THE PLUNGER CAME OUT OF THE BACK. THEREFORE BALLOON COULD NOT BE INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20382982 ↗
• MalfunctionJun 3, 2024

  ENDOSCOPIC SINUS SURGERY- FRONTAL BALLOON SINUSOTOMY. ATTEMPTED NAVIGATED BALLOON DILATION WITHOUT SUCCESS DUE TO MEDTRONIC FRONTAL BALLOON MALFUNCTION ¿ THE BALLOON WOULD NOT FULLY INFLATE. SURGEON ATTEMPTED TROUBLESHOOTING MULTIPLE TIMES ¿ INSTRUMENT UNABLE TO COMPLETE TASK. MANUFACTURER RESPONSE FOR INSTRUMENT, ENT MANUAL SURGICAL, NUVENT ¿ (PER SITE REPORTER). NO RESPONSE AS OF YET. MANUFACTURER RESPONSE FOR INSTRUMENT, ENT MANUAL SURGICAL, NUVENT¿ (PER SITE REPORTER). NO RESPONSE AS OF YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19446456 ↗
• MalfunctionFeb 21, 2024Break; Break

  IT WAS REPORTED THAT THE BALLOON WAS TAKEN OUT OF THE BOX AND USED ON THE PATIENT IN THE FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) CASE. BALLOON WAS NOT INFLATING PROPERLY AFTER USE IN THE MIDDLE OF THE PROCEDURE. WHEN THE INFLATOR WAS CHECKED TO ENSURE PROPER PRIMING, IT FELL APART IN TWO PIECES IN THE SCRUB TECH'S HANDS. THE SCRUB STATED 'THAT THEY DID WHAT THEY ALWAYS DO". THE SCRUB IS VERY FAMILIAR WITH PRODUCTS AND UTILIZES THEM FREQUENTLY IN PROCEDURE. BALLOON SEEKR DID NOT CONTRIBUTE TO THE INFLATOR EVENT. BUT DUE TO WASTED PRODUCT IT WAS CREDITED. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18745284 ↗
• MalfunctionDec 16, 2019Material Separation; Use of Device Problem; Material Separation; Use of Device Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT DURING THE PROCEDURE, THE INFLATOR CAME APART AND USED A SYRINGE TO DEFLATE IN LEFT FRONTAL SINUS. THE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. THE PATIENT WAS NOT HARMED. ON FOLLOW UP, IT WAS CONFIRMED THAT THE HCP TRIED TO CONNECT THE INFLATOR BACK BUT IT DID NOT WORK AND THEY USED A SYRINGE TO DEFLATE DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY. THERE WAS A DELAY OF LESS THAN 5 MINUTES. IT WAS NOTED THAT IT WAS THE INITIAL USE OF THE DEVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9475039 ↗