MesireTM Guide - Sinus Guide Catheter MSG110Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18904224901534), received between Jan 3, 2019 and Jan 3, 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 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS USING THE MESIRE SYSTEM TO DILATE SIX (6) SINUSES. THE PHYSICIAN WAS ABLE TO DO BOTH SPHENOID SINUSES. HE THEN ATTEMPTED TO DO LEFT FRONTAL AND WAS UNABLE TO ACCESS THE FRONTAL RECESS BECAUSE OF THE PATIENT ANATOMY. HE THEN MOVED TO THE MAXILLARY GUIDE TO DO THE RIGHT MAXILLARY. PATIENT HAD A LARGE MIDDLE TURBINATES THAT HE TRIED TO MEDIALIZE, PATIENT HAD LONG UNCINATE THAT WAS PASTED AGAINST ETHMOID BULLA. IN THE PROCESS OF TRYING TO GET TIP OF GUIDE AROUND UNCINATE THE OUTER LUMEN OF THE GUIDE SEPARATED FROM 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 8211322 ↗