RELIEVA FLEX GC110RFRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705031063488), received between Aug 29, 2018 and Aug 29, 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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 29, 2018Material Fragmentation; Material Fragmentation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ATTEMPT TO IRRIGATE THE MAXILLARY SINUS DURING THE PRIMARY PROCEDURE ON (B)(6) 2018, THE BLUE TIPS AT THE END OF THE RELIEVA FLEX SINUS GUIDE CATHETER, M-110 (GC110RF) CAME OFF ON BOTH CATHETERS FROM THE SAME LOT (170112A-PC). ADDITIONAL FOLLOW-UP WAS PERFORMED ON (B)(6) 2018, AND THE SALES REPRESENTATIVE STATED THAT THE TIP WAS STILL CONNECTED TO THE GUIDE CATHETER. IT WAS REPLACED, AND THE SAME ISSUE OCCURRED WITH THE SECOND CATHETER. THE TWO GUIDE CATHETERS WERE RETURNED FOR EVALUATION. ONE OF THE GUIDE CATHETERS WAS FOUND TO BE MISSING THE BLUE TIP. THE SALES REPRESENTATIVE WAS CONTACTED AGAIN FOR CLARIFICATION, AND SHE REPORTED THAT WHEN THE GUIDE CATHETER WAS REMOVED FROM THE PATIENT THE TIP WAS STILL PARTIALLY ATTACHED TO THE DEVICE; THE BLUE TIP FELL OFF DURING THE INSPECTION OF THE GUIDE CATHETER OUTSIDE OF THE PATIENT¿S ANATOMY. A THIRD GUIDE CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7829635 ↗