RELIEVA SPINPLUS RSP0516MFSZRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705031232829), received between Dec 3, 2025 and Dec 3, 2025 — classified as 1 injury.

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.

• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE "PATIENTS¿ RIGHT EYE LID AND LOWER LID FILLED WITH SALINE. THIS OCCURRED DURING THE IRRIGATION PROCEDURE OF THE RIGHT MAXILLARY SINUS BALLOONING. POST SURGERY INVESTIGATION REVEALED THROUGH THE MEDTRONIC STEALTH NAVIGATION SYSTEM A POSSIBLE DEHISCENCE THAT DID NOT SHOW UP VERY WELL IN CT SCANS. SURGERY WAS ENDED AND PATIENT WAS WOKEN UP TO CONFIRM VISION STATUS, FOR SAFETY REASONS." IT WAS SUBSEQUENTLY REPORTED THAT THERE WAS NO ERROR OF THE PRODUCT, BUT A REACTION THE PATIENT HAD DURING THE IRRIGATION PROCESS." ADDITIONALLY, THE PRODUCT WAS THROWN AWAY.

  Patient problems: Swelling/ Edema

  MAUDE report 23704030 ↗