RELIEVA SPINPLUS RSP0516MFSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031232839), received between Jun 7, 2018 and Sep 7, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Expiration Issue” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  ON (B)(6) 2018, THE HEALTHCARE PROFESSIONAL REPORTED THAT THERE WAS A TEAR IN THE PACKAGING OF THE RELIEVA SPINPLUS, 5MM 3 GUIDES KIT (RSP0516MFS / 180307B-PC) AND A LITTLE PIECE OF WHAT APPEARED TO BE CARDBOARD WAS INSIDE THE PACKAGING. THE SPINPLUS BALLOON KIT WAS NOT USED FOR THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OR ADVERSE EVENT ASSOCIATED WITH THE ISSUE AS ANOTHER BALLOON KIT WAS OPENED AND USED FOR THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7855724 ↗
• MalfunctionJun 7, 2018Device Expiration Issue; Device Expiration Issue

  ACCLARENT WAS INFORMED ON (B)(6) 2018, OF AN EVENT WHICH OCCURRED ON THE SAME DAY DURING A BALLOON SINUPLASTY PROCEDURE INVOLVING A RELIEVA SPINPLUS KIT, 3 GUIDES, 5 MM KIT (RSP0516MFS / 160427B-PC). THE SPINPLUS BALLOON CATHETER RUPTURED DURING THE TREATMENT OF THE LEFT MAXILLARY SINUS. THE BALLOON CATHETER WAS REPLACED WITH ANOTHER BALLOON FROM LOT NUMBER 170127A-PC AND THE CASE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION ASSOCIATED WITH THE EVENT; HOWEVER, IT WAS DETERMINED THAT THE SPINPLUS BALLOON CATHETER USED FOR THIS PROCEDURE HAD EXPIRED ON 04/27/2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7581030 ↗