MesireTM Guide - Sinus Guide Catheter MSG070Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18904224901510), received between Jan 2, 2019 and Jan 2, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionJan 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS DOING AN OFFICE BALLOON DILATATION ON ALL SIX (6) SINUSES ON A PATIENT WITH LARGE MIDDLE TURBINATES. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY DILATE BOTH THE SPHENOID SINUSES WITHOUT ANY ISSUES. THE PHYSICIAN STARTED TO DO LEFT FRONTAL SINUS WITH MINIMAL SPACE IN THE OSTEOMEATAL COMPLEX, IN ATTEMPT TO REPOSITION THE TIP OF THE GUIDE CATHETER HE USED THE WINGS TO TRY AND TORQUE THE TIP IN A NEW POSITION. THE WINGS A PART OF OUTER LUMEN SEPARATED FROM THE INNER LUMEN. THE PHYSICIAN RETRACTED THE SYSTEM. THERE WAS NO PATIENT INJURY REPORTED. THE PROCEDURE WAS COMPLETED USING A COMPETITOR CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8207749 ↗