RELIEVA FLEX GC090RFRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031063457), received between May 22, 2018 and May 22, 2018 — classified as 2 malfunctions.

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

• MalfunctionMay 22, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCLARENT WAS INFORMED ON (B)(6) 2018, OF AN EVENT WHICH OCCURRED DURING THE PRIMARY HYBRID BALLOON SINUPLASTY PROCEDURE WITH TURBINATE REDUCTION AND PARTIAL ETHMOIDECTOMY ON (B)(6) 2018, IN WHICH A RELIEVA® FLEX SINUS GUIDE CATHETER M-90 (GC090RF / 170124C-PC) WAS USED. THE HEALTHCARE PROFESSIONAL REPORTED THAT THE SPACE BETWEEN THE ETHMOID BULLA AND THE UNCINATE PROCESS WAS TIGHT, WHICH MADE IT DIFFICULT TO ACCESS THE SINUS. THE BLUE TIP ON THE FLEX GUIDE CATHETER BECAME DETACHED AND FELL OFF WITHIN THE MIDDLE MEATUS AFTER THE MAXILLARY SINUS WAS DILATED. THE TIP WAS RETRIEVED AND DISCARDED. THE GUIDE CATHETER HAD BEEN USED THREE TIMES BEFORE THE BLUE TIP BECAME SEPARATED. THE PROCEDURE WAS CONTINUED WITHOUT THE USE OF THE TIP; THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE AND WITHOUT ANY PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7532061 ↗
• MalfunctionMay 22, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCLARENT WAS INFORMED ON (B)(6) 2018, OF AN EVENT WHICH OCCURRED DURING THE PRIMARY HYBRID BALLOON SINUPLASTY PROCEDURE WITH TURBINATE REDUCTION AND PARTIAL ETHMOIDECTOMY ON (B)(6) 2018, IN WHICH A RELIEVA® FLEX SINUS GUIDE CATHETER M-90 (GC090RF / 170124C-PC) WAS USED. THE HEALTHCARE PROFESSIONAL REPORTED THAT THE SPACE BETWEEN THE ETHMOID BULLA AND THE UNCINATE PROCESS WAS TIGHT, WHICH MADE IT DIFFICULT TO ACCESS THE SINUS. THE BLUE TIP ON THE FLEX GUIDE CATHETER BECAME DETACHED AND FELL OFF AFTER THE MAXILLARY SINUS WAS DILATED. THE TIP FELL OFF OUTSIDE OF THE PATIENT¿S ANATOMY; IT WAS DISCARDED. THE GUIDE CATHETER HAD BEEN USED THREE TIMES BEFORE THE BLUE TIP BECAME SEPARATED. THE PROCEDURE WAS CONTINUED WITHOUT THE USE OF THE TIP; THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE AND WITHOUT ANY PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7531931 ↗