RELIEVA SPINPLUS NAV RSP0616MFSNZRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705031245430), received between Aug 4, 2021 and Jan 19, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING AN IN-OFFICE BALLOON SINUPLASTY PROCEDURE, THE TIP OF THE NAVIGATED WIRE OF THE SPINPLUS NAV 6X16MM 3 GUIDE (RSP0616MFSNZ) BECAME TOO KINKED FOR THE SURGEON TO COMPLETE THE PROCEDURE WITH THE DEVICE. "IT WAS PERMANENTLY KINKED IN THREE DIFFERENT LOCATIONS." IT WAS REPORTED THAT THERE WAS A 30 MINUTE DELAY DURING THE PROCEDURE. NO PATIENT ADVERSE EVENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24112340 ↗
• MalfunctionAug 4, 2021Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IN-OFFICE PRIMARY HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE THAT WAS AIMED TO TARGET ALL SIX SINUSES; IT WAS REPORTED THAT ACCURACY OF THE 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSNZ / 210525A-PC) WAS ¿OFF¿ ON THE TRUDI NAVIGATION SYSTEM. THE POSITIONING WAS VERIFIED AND ¿EVERYTHING WAS GREEN.¿ THE PROBE ACCURACY WAS REPORTED TO ¿LOOKED GOOD.¿ THE SPINPLUS NAVIGATION BALLOON WAS REPLACED, BUT THERE WAS NO RESOLUTION. THE PROCEDURE WAS CONTINUED AND COMPLETED WITH A REPLACEMENT PRODUCT. THE REPORTED ISSUE OCCURRED AFTER THE BALLOON HAD BEEN INFLATED TWICE. THE GUIDE / BALLOON WAS NOT FLUSHED PRIOR TO USE. THE BALLOON WAS APPROPRIATELY FOLDED PRIOR TO INSERTION. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ADDITIONAL INFORMATION WAS RECEIVED ON 20 JULY 2021. THE INFORMATION INDICATED THAT THE POSITION WAS VERIFIED INTERNALLY USING ANATOMICAL LANDMARKS AND EXTERNALLY USING ALONG THE BRIDGE OF THE NOSE. ALL STATUS SYMBOLS ON THE WORKSTATION INDICATED PROPERLY CONNECTED INSTRUMENTS AND PROPERLY PLACED WITHIN THE TRUDI ZONE WITHOUT METAL INTERFERENCE. THERE WERE N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12277822 ↗