RELIEVA TRACT RT1640ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031462649), received between Sep 14, 2020 and Sep 4, 2024 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2024Material Rupture; Material Separation; Material Rupture; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IN-OFFICE TOTAL SINUS BALLOON DILATION PROCEDURE ON (B)(6) 2024, A 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN / 240422B-PC) STOPPED NAVIGATING ON THE TRUDI NAVIGATION SYSTEM HALFWAY THROUGH THE PROCEDURE. THE TRUDI NAVIGATION SYSTEM DISPLAYED AN ERROR THAT INDICATED THE DEVICE NEEDED TO BE CHANGED. THE CABLE WAS RESEATED MULTIPLE TIMES WITHOUT RESOLUTION AND THE SPINPLUS NAVIGATION BALLOON WAS REPLACED AND THE ISSUE WAS RESOLVED. DURING THE SAME PROCEDURE, IT WAS REPORTED THAT A 16MM X 40MM RELIEVA TRACT BALLOON (RT1640A / 230911B-PC) POPPED ON THE FIRST INFLATION. IT WAS REPORTED THAT THE BALLOON CATHETER PORTION BECAME UNATTACHED FROM THE PROXIMAL EDGE OF THE CATHETER. THE RELIEVA TRACT BALLOON CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20138080 ↗
• MalfunctionJun 6, 2024

  SINUS BALLOON POPPED DURING INFLATION IN PATIENT AROUND PRESSURE OF 10 ATM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19475871 ↗
• InjuryApr 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT ENT (EAR, NOSE & THROAT) PROCEDURE WITH ACCLARENT DEVICES ON (B)(6) 2024 EXPERIENCED BRUISING AND SWELLING BELOW THE EYES AND SWELLING AROUND THE LOWER JAW. IT WAS ALSO REPORTED THAT THE PHYSICIAN HAD ADMITTED THE PATIENT FOR A POST-OP CT SCAN, AND IT WAS CONFIRMED THAT THERE WAS NO CRIBRIFORM PLATE FRACTURE PRESENT. THE CALLER REPORTED THAT THERE WAS NO OTHER MEDICAL INTERVENTION PROVIDED TO THE PATIENT. THE CALLER REPORTED THAT THE PATIENT IS IN STABLE CONDITION. THERE ARE NO REPORTED MALFUNCTIONS WITH ANY ACCLARENT DEVICES USED DURING THE CASE.

  Patient problems: Ecchymosis; Swelling/ Edema

  MAUDE report 19105775 ↗
• InjuryMar 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A BALLOON SINUPLASTY (BSP) PROCEDURE, THE PATIENT SUSTAINED AN INJURY TO HER CAROTID ARTERY THAT RESULTED IN HER SUFFERING A CATASTROPHIC STROKE. THE REPORTED DEVICES USED DURING THE PROCEDURE WERE: A RELIEVA TRACT BALLOON (RT1640A / 211202A-PC), TWO 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN), ONE FROM LOT 220419A-PC AND ONE FROM LOT 220504A-PC, A DISPOSABLE TRUDI PROBE 0-DEGREE, 5IN (TDP0005 / 210201B-PC), AN ACCLARENT BALLOON INFLATION DEVICE (BID30 / 96375250), AND A TRUDI NAV CABLE (TDNC001 / 211206C-PC) AND THE TRUDI NAVIGATION SYSTEM. IT IS REPORTED THAT THE PATIENT BELIEVED THAT THE ACCLARENT NAVIGATION BALLOON DILATION SYSTEM AND ITS COMPONENT PARTS, INCLUDING ANY AI (ARTIFICIAL INTELLIGENCE SOFTWARE) MAY HAVE MALFUNCTIONED AND FAILED TO PERFORM AS INTENDED DURING THE PROCEDURE, AND THAT AS A RESULT, THE PATIENT¿S CAROTID ARTERY WAS INJURED.

  Patient problems: Perforation of Vessels; Stroke/CVA

  MAUDE report 18962771 ↗
• MalfunctionMar 6, 2024

  DURING SEPTOPLASTY PORTION OF SURGERY, SINUS BALLOON POPPED AT A PRESSURE OF 4ATM, MANUFACTURER¿S REPORTED PRESSURE MAX SHOULD BE AT 8ATM, PATIENT UNINJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18844977 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT A PHYSICIAN COMMENTED THAT HE RECEIVED A PATIENT WITH A SEPTAL HEMATOMA AFTER UNDERGOING A PROCEDURE WITH A RELIEVA TRACT PROCEDURE TO ADDRESS NASAL OBSTRUCTION. THE PHYSICIAN DRAINED THE PATIENT AND THE HEMATOMA WAS RESOLVED. ON 20-JUN-2022, DETAILED ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT ON (B)(6) 2022, A MALE PATIENT UNDERWENT A BALLOON SINUPLASTY PROCEDURE TO TREAT THE SINUS ISSUE AND A RELIEVA TRACT BALLOON (RT1640A / LOT# UNKNOWN) WAS USED DURING THE PROCEDURE TO CREATE SPACE. THE SEPTAL HEMATOMA WAS ASSUMED TO HAVE OCCURRED ON (B)(6) 2022. IT WAS CONFIRMED ON POST-OPERATIVE DAY 8 BY DR. (B)(6) ON COMPUTED TOMOGRAPHY (CT) IMAGING ON (B)(6) 2022. THE PATIENT DID NOT HAVE ANY PREVIOUS SINUS TREATMENT BEFORE THE INDEX BSP PROCEDURE OR WITH THE RELIEVA TRACT; IT IS UNKNOWN IF THE PATIENT HAS A HISTORY OF HEMATOMAS. IN THE PHYSICIAN¿S OPINION, THE PROCEDURE RISK AND SUBMUCOSAL RUPTURE MAY HAVE CAUSED OR CONTRIBUTED TO THE SEPTAL HEMATOMA. THE SEPTAL HEMATOMA WAS TREATED VIA SUCCESSFUL OPERATIVE INCISION AND DRAINAGE (I&D). THE DRAINAGE WAS COMPLETED IN ONE VISIT. THE PATIENT IS REPORTED TO BE DOING WELL AND WAS

  Patient problems: Hematoma

  MAUDE report 14830857 ↗
• InjurySep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT AT THE 6-WEEK FOLLOW-UP EXAM FOR A POST-FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE THAT TOOK PLACE IN AUGUST 2020, THE PATIENT WHO IS A SMOKER AND HAS A HISTORY OF SIGNIFICANT SINUS AND NASAL DISEASE PRESENTED WITH A SEPTAL PERFORATION. IT WAS REPORTED THAT THE PHYSICIAN BELIEVES THAT THE ROOT CAUSE OF THE ISSUE IS DUE TO THE 16 X 40MM RELIEVA TRACT BALLOON DILATION SYSTEM (RT1640A / LOT# UNKNOWN). IT WAS ALSO REPORTED THAT THE PHYSICIAN HAD PREVIOUSLY STATED THAT HE ¿WAS NOT HAPPY WITH HOW THE PATIENT WAS HEALING AFTER THE PROCEDURE.¿ NO MEDICAL INTERVENTION WAS PROVIDED TO ADDRESS THE SEPTAL PERFORATION. ADDITIONAL INFORMATION WAS PROVIDED ON 04 SEPTEMBER 2020. THE PHYSICIAN SHARED THAT THE PATIENT IS A SMOKER AND HAD NOT SEEM TO BE HEALING WELL. THERE WERE A LOT OF CRUSTING IN THE NOSE. WHEN THE PATIENT RETURNED FOR THE FOLLOW-UP VISIT, THERE WAS A PERFORATION IN THE SEPTUM THAT HE BELIEVES WAS CAUSED BY THE RELIEVA TRACT BALLOON. THE PATIENT¿S SINUS AND NASAL ANATOMY WAS CONSIDERED NORMAL. THE PATIENT DID NOT HAVE ANY PREVIOUS SURGICAL COMPLICATIONS. IT WAS REPORTED THAT THE PATIENT IS UNDER CARE FOR A MIXTURE OF USUAL TYPES O

  Patient problems: Perforation

  MAUDE report 10532699 ↗