RELIEVA SPINPLUS RSP0616MFSRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031232389), received between Nov 29, 2017 and Feb 12, 2021 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Crack” (2 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2021Material Fragmentation; Material Fragmentation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, DURING THE TREATMENT OF THE FIRST SINUS IN THE PROCEDURE, THE FRONTAL GUIDE TIP WAS PLACED ON THE TIP OF THE 6MM X 16MM RELIEVA SPINPLUS BALLOON CATHETER (RSP0616MFS / 200803A-PC) AND WHEN THE BALLOON WAS ADVANCED DURING TREATMENT OF THE FRONTAL SINUS, A PIECE OF THE BALLOON SHEATH BROKE OFF IN THE PATIENT¿S NOSE. THE PATIENT¿S ANATOMY WAS UNREMARKABLE; THERE WAS NO ISSUE RELATED TO THE PATIENT¿S ANATOMY THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT; THERE WAS NO ISSUE ENCOUNTERED WHEN THE DEVICE WAS INTRODUCED INTO THE PATIENT¿S ANATOMY. SUCTION WAS USED TO REMOVE THE PIECE OF BROKEN SHEATH FROM THE PATIENT¿S ANATOMY. IT TOOK 2 MINUTES TO OPEN ANOTHER 6MM X 16MM RELIEVA SPINPLUS BALLOON CATHETER (RSP0616MFS), THE PROCEDURE WAS THEN RESUMED AND WAS SUCCESSFULLY COMPLETED. IT WAS REPORTED THAT A 0-DEGREE SCOPE WAS USED AND THE GUIDE TIP WAS DETERMINED NOT TO BE THE SOURCE OF THE REPORTED ISSUE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11325439 ↗
• MalfunctionJun 9, 2020Crack; Crack

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IN-OFFICE PRIMARY BALLOON SINUPLASTY (BSP) PROCEDURE ON (B)(6) 2020, THE TARGETING THE FRONTAL, MAXILLARY, AND SPHENOID SINUSES, THE TIP OF THE FRONTAL GUIDE CATHETER ON THE 6MM 3 GUIDES RELIEVA SPINPLUS KIT (RSP0616MFS / 190822A-PC) CRACKED WHEN IT WAS POSITIONED TO DEPLOY THE BALLOON CATHETER. IT WAS REPORTED THAT THE CRACK IN THE GUIDE CATHETER WAS PRIOR TO ANY INFLATIONS OF THE BALLOON CATHETER; THE TIP CRACKED BUT DID NOT COMPLETELY BREAK OFF. THE PHYSICIAN REMOVED THE FRONTAL GUIDE TIP AND CONFIRMED THAT NO PORTION OF THE DAMAGED TIP WAS LEFT BEHIND. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER 6MM 3 GUIDES RELIEVA SPINPLUS KIT (RSP0616MFS). THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10136364 ↗
• MalfunctionMar 25, 2020Material Separation; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IN-OFFICE BALLOON SINUPLASTY (BSP) PROCEDURE, THE TIP OF THE 6MM RELIEVA SPIN PLUS BALLOON CATHETER (RSP0616MFS / LOT# UNKNOWN) BROKE OFF DURING THE TREATMENT OF THE FRONTAL SINUS. IT WAS REPORTED THAT THE TOP OF THE BALLOON WAS BENT, AND THE TIP SEPARATED AND BROKE OFF AS THE BALLOON WAS BEING INFLATED USING THE ACCLARENT SE INFLATION DEVICE (SEID / LOT# UNKNOWN). THE PHYSICIAN REMOVED THE SEPARATED TIP FROM THE PATIENT¿S ANATOMY. IT WAS CONFIRMED THAT THE BALLOON WAS APPROPRIATELY FOLDED PRIOR TO ITS INSERTION INTO THE PATIENT¿S FRONTAL SINUS CAVITY. THE PROCEDURE WAS COMPLETED USING A NEW SPIN PLUS BALLOON CATHETER AND A NEW ACCLARENT SE INFLATION DEVICE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9880076 ↗
• MalfunctionFeb 3, 2020Physical Resistance/Sticking

  STAFF REPORTED TO THE CHARGE NURSE THAT THE WIRE OF THE DEVICE WOULD NOT SLIDE PROPERLY AND THAT IT WAS "STICKING". DEVICE WAS REMOVED FROM SERVICE AND REPLACED WITH A NEW STERILE SUPPLY. THE DEVICE WAS GIVEN TO MATERIALS MANAGEMENT TO HANDLE A RETURN TO THE MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9659244 ↗
• MalfunctionJan 14, 2020Crack; Crack

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY BALLOON SINUPLASTY (BSP) PROCEDURE ON (B)(6) 2019, TARGETING THE FRONTAL, MAXILLARY, AND SPHENOID SINUSES, THE FRONTAL GUIDE CATHETER TIP ON THE 6MM 3 GUIDES RELIEVA SPINPLUS KIT (RSP0616MFS / 190627A-PC) CRACKED WHEN IT WAS INSERTED INTO THE PATIENT¿S NASAL CAVITY. IT WAS REPORTED THAT THE TIP CRACKED BUT DID NOT BECOME SEPARATED FROM THE REST OF THE GUIDE CATHETER. NO PIECES FELL INTO OR WERE LEFT IN THE PATIENT¿S ANATOMY. THE PHYSICIAN VERIFIED USING THE ENDOSCOPE (STRYKER) AND CONFIRMED THAT THERE WAS NO PARTICLE LEFT IN THE PATIENT. THE DEVICE WAS REPLACED WITH ANOTHER 6MM 3 GUIDES RELIEVA SPINPLUS KIT (RSP0616MFS), AND THE PHYSICIAN COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9589485 ↗
• MalfunctionOct 22, 2018Fracture; Fracture

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE ON (B)(6) 2018, THE CLEAR PLASTIC PORTION ON FRONTAL GUIDE CATHETER THAT IS PART OF THE RELIEVA SPINPLUS KIT, 3 GUIDES, 6MM (RSP0616MFS / 180312A-PC) BECAME CRACKED / BROKEN DURING THE TREATMENT OF THE LEFT FRONTAL SINUS. PER THE ACCLARENT SALES REPRESENTATIVE, THE PATIENT¿S ANATOMY WAS CHALLENGING TO MANEUVER AROUND; THE PLASTIC PORTION ON THE GUIDE CATHETER BROKE BUT DID NOT BECOME SEPARATED FROM THE GUIDE CATHETER SHAFT. THE SPINPLUS BALLOON CATHETER HAD BEEN INFLATED TWO TO THREE TIMES BEFORE THE ISSUE WITH THE FRONTAL GUIDE CATHETER OCCURRED. THE PHYSICIAN HAD PERFORMED A SEPTOPLASTY BEFORE THE ATTEMPT TO TREAT THE LEFT FRONTAL SINUS. THE SPINPLUS BALLOON CATHETER WAS REPLACED AND THE PROCEDURE WAS RESUMED AND SUBSEQUENTLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7992782 ↗
• MalfunctionFeb 13, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCLARENT WAS INFORMED ON (B)(4) 2018, OF AN EVENT THAT OCCURRED DURING THE PRIMARY BALLOON SINUPLASTY PROCEDURE ON THE SAME DAY, THAT INVOLVED A RELIEVA SPINPLUS® BALLOON SINUPLASTY SYSTEM (RSP0616MFS) FROM LOT#: 170712A-PC. THE SPINPLUS BALLOON CATHETER WAS BEING USED TO TREAT THE MAXILLARY SINUS WHEN THE TIP OF THE MAXILLARY GUIDE CATHETER BECAME DETACHED FROM THE SHAFT AND FELL INTO THE MIDDLE MEATUS. THERE WAS NO INJURY TO THE NASAL OR SINUS TISSUE FROM THE TIP DETACHMENT; THE GUIDE CATHETER TIP WAS RETRIEVED FROM THE SINUS CAVITY USING ALLIGATOR FORCEPS. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATIONS AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7267185 ↗
• MalfunctionNov 29, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCLARENT WAS INFORMED ON (B)(4) 2017, FOR AN EVENT THAT OCCURRED ON (B)(6) 2017 INVOLVING A RELIEVA SPINPLUS KIT, 3 GUIDES, 6MM, 5PK (LOT# NOT AVAILABLE). DURING A PRIMARY BALLOON SINUPLASTY PROCEDURE, WHILE THE BALLOON CATHETER WAS BEING ADVANCED INTO THE LEFT FRONTAL SINUS, THE BLUE TAPERED TIP OF THE BALLOON CATHETER SEPARATED AND FELL INTO THE OSTIOMEATAL COMPLEX. THE SEPARATED TIP WAS RETRIEVED BY SUCTION. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE. ANOTHER DEVICE WAS OPENED AND THE PROCEDURE WAS RESUMED. NO NON-ACCLARENT DEVICES WERE USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7069500 ↗