RELIEVA FLEX GC070CRFRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705031063426), received between Nov 21, 2018 and Nov 21, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 18, 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.

• MalfunctionNov 21, 2018Material Fragmentation; Material Fragmentation

  ACCLARENT WAS INFORMED ON 10/30/2018, OF AN EVENT THAT OCCURRED ON (B)(6) 2018, INVOLVING THE RELIEVA FLEX SINUS GUIDE CATHETER F-70C (GC070CRF / 180405A-PC). DURING THE HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, THE BLUE TIP ON THE RELIEVA FLEX SINUS GUIDE CATHETER BROKE OFF THE GUIDE CATHETER. IT WAS REPORTED THAT NOTHING WAS LEFT INSIDE THE PATIENT¿S ANATOMY; THERE WAS NO HARM OR ADVERSE EVENT TO THE PATIENT. ANOTHER GUIDE CATHETER WAS OPENED AS A REPLACEMENT AND THE PROCEDURE WAS COMPLETED. THE GUIDE CATHETER AND THE SEPARATED BLUE TIP WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8096703 ↗