Thoraflex™ Hybrid THP3038X150ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05037881026855), received between Sep 5, 2024 and Mar 11, 2025 — classified as 1 death, 1 injury.

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 18, 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.

• DeathMar 11, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE COMPONENT THAT THE DEVICE DEFICIENCY WAS REPORTED IS TO BE RELATED TO A THORAFLEX HYBRID DEVICE. THORAFLEX HYBRID PROCEDURE TOOK PLACE ON (B)(6)2024. THE ASCENDING AORTIC GRAFT FROM THE PREVIOUS SURGERY WAS THEN TRIMMED, AND THE PROXIMAL THORAFLEX GRAFT (30MM) TRIMMED AND BEVELLED TO FIT THIS. A PLANNED AORTIC VALVE PROCEDURE WAS ALSO CARRIED OUT. AN ENDOLEAK WAS REPORTED AS BEING PRESENT AT THE END OF THE PROCEDURE. NO ADVERSE EVENTS OR DEVICE DEFICIENCIES WERE REPORTED AT THE TIME OF THE PROCEDURE. NO ISSUES WERE REPORTED ON THE POST THORAFLEX HYBRID PROCEDURE ASSESSMENT. THE SUBJECT UNDERWENT THE EXTENSION PROCEDURE DURING THE SAME HOSPITAL ADMISSION. THE EXTENSION PROCEDURE WAS REPORTED TO HAVE TAKEN PLACE ON THE (B)(6)2024 (VARIOUS DEVICE ARE LISTED: 2 X GORE CTAG, 3 X GORE VIABAHN). NO ENDOLEAK WAS REPORTED AT THE END OF THE PROCEDURE BUT THE DEVICE DEFICIENCY KINKING/ TWISTING WAS REPORTED. PATIENT OUTCOME: THE SUBJECT IS REPORTED TO HAVE DIED ON (B)(6)2024. NO AUTOPSY WAS PERFORMED. THE PRIMARY CAUSE OF DEATH WAS CATEGORISED AS "DISEASE UNDER STUDY".

  Patient problems: Adult Respiratory Distress Syndrome; Insufficient Information; Ruptured Aneurysm

  MAUDE report 21570723 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE INDICATION FOR SURGERY WAS AN AORTIC ANEURYSM AND DISSECTION WITH A TYPE 2 ENDOLEAK IN THE DESCENDING THORACIC AORTA. SHAPE OF THE ANEURYSM AND DEBAKEY TYPE. AN ELECTIVE THORAFLEX HYBRID PLEXUS WAS PERFORMED ON (B)(6) 2024. THE ASCENDING AORTIC GRAFT FROM THE PREVIOUS SURGERY WAS THEN TRIMMED, AND THE PROXIMAL THORAFLEX GRAFT (30MM) TRIMMED AND BEVELLED TO FIT THIS. AT THE POST INDEX PROCEDURE ASSESSMENT THE GRAFT WAS PATENT WITH NO THORAFLEX HYBRID DEVICE DEFORMATIONS. ON THE (B)(6) 2024, 6 DAYS POST INDEX PROCEDURE, A COMPUTED TOMOGRAPHY ANGIOGRAPHY SCAN WAS PERFORMED WHICH SHOWED A LEAKING THORACOABDOMINAL AORTIC ANEURYSM (TAAA). THE PATIENT WAS EXAMINED BY CARDIOVASCULAR SURGEON AND DEEMED A CANDIDATE FOR EMERGENCY ENDOVASCULAR TAAA REPAIR USING PARALLEL ENDOGRAFTS. SURGERY WAS PERFORMED -TEVAR WITH PARALLEL GRAFTS FOR CELIAC, SPINAL MUSCULAR ATROPHY, AND LEFT RENAL VIA RIGHT FEMORAL AND LEFT COMMON CAROTID CUTDOWNS. THE SITE HAVE DEEMED THIS TO BE AN UNANTICIPATED EVENT, WHICH IS NOT RELATED TO THE PROCEDURE OR THE DEVICE BUT RELATED TO A PRE-EXISTING CONDITION. THE MEDICAL MONITOR WHO OVERSEES THE SAFETY OF THE STUDY HAS DEEMED THIS EVENT TO BE POSSIBLY RELATED TO THE DEV

  Patient problems: Ruptured Aneurysm

  MAUDE report 20146488 ↗