Thoraflex™ Hybrid THA3036X150ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05037881027050), received between Feb 24, 2025 and Feb 26, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  EVENT OF WORSENING TYPE 1B ENDOLEAK REPORTED FORM EXTEND STUDY (B)(4). ON POST OPERATIVE DAY 722(INDEX PROCEDURE)/284(EXTENSION PROCEDURE), THE SUBJECT HAD A (COMPUTERISED TOMOGRAPHY) CT SCAN ON (B)(6) 2026 WHICH SHOWED MULTIPLE STABLE UNCLASSIFIED ENDOLEAKS IN THE PROXIMAL STENT AND MIDPORTION OF THE STENT WITH OVERALL STABLE AGGREGATE DIAMETER MEASURING UP TO 7.2CM. ON (B)(6) 2025, CTA (COMPUTED TOMOGRAPHY ANGIOGRAPHY) REVEALED INTERVAL GROWTH OF THE PROXIMAL DESCENDING AORTA MEASURING A MAXIMUM OF 7.1 CM IN DIAMETER. FOLLOW-UP IMAGING IN (B)(6) 2025 SHOWED ONGOING LEAK FROM THE DISTAL GRAFT. TREATMENT OF THE EVENT ON (B)(6)2026 INCLUDED EXTENSION THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) VIA RIGHT CFA (UNDERSTOOD TO BE COMMON FEMORAL ARTERY) CUTDOWN. THE VASCULAR PROCEDURE INCLUDED PERCUTANEOUS ACCESS OF THE RIGHT FEMORAL ARTERY WITH A 7-FRENCH SHEATH, A RIGHT ILIAC ANGIOGRAM, AND A STENTING OF THE RIGHT COMMON ILIAC ARTERY AND EXTERNAL ILIAC. TYPE 1B ENDOLEAK OF A THORACIC ENDOVASCULAR AORTIC REPAIR GRAFT DONE PREVIOUSLY AFTER THE PATIENT HAS AN EXTENSIVE HISTORY OF TYPE A AORTIC DISSECTION AND EXTENSIVE RECONSTRUCTION. THIS INTERVENTION WAS NOT REQUIRED AS A RESULT OF A DEVI

  Patient problems: Clinical Endoleak

  MAUDE report 24452309 ↗
• InjuryNov 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  EVENT OF INCREASED ANEURYSMAL DILATION REPORTED FROM EXTEND STUDY (B)(6); SUBJECT UNDERWENT AN ELECTIVE OPEN SURGICAL REPAIR OF THE AORTA WITH A THORAFLEX HYBRID ANTE-FLO DEVICE ON (B)(6) 2025. INDICATION FOR SURGERY WAS TO TREAT CHRONIC (>90DAYS) DEBAKEY TYPE IIIA AORTIC DISSECTION. SUBJECT EXPERIENCED AN ADVERSE EVENT (AE) OF INCREASED ANEURYSMAL DILATION'. FURTHER COMMENTS STATE "PENDING LEFT SUBCLAVIAN PLUG AND TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR) EXTENSION. CTA (COMPUTED TOMOGRAPHY ANGIOGRAPHY) (B)(6) 2025 SHOWED FALSE LUMEN FILLING. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00090 TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0344.

  Patient problems: Aneurysm expansion

  MAUDE report 23484505 ↗
• InjuryMar 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  EVENT OF ENDOLEAK REPORTED FROM EXTEND STUDY (NCT05639400). ON POST OPERATIVE DAY 309 (15NOV24), A CT SCAN PERFORMED SHOWED AN ENDOLEAK OF AN UNDETERMINED TYPE. TREATMENT OF THE EVENT IS TO INCLUDE A PLANNED TEVAR WHICH IS TO BE COMPLETED AND AN EXTENSION PROCEDURE IS PLANNED. THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00020 TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0178.

  Patient problems: Clinical Endoleak

  MAUDE report 21582386 ↗
• MalfunctionFeb 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING IMPLANTATION THE PHYSICIAN USED A LUNDERGUIST WIRE WITH A THORAFLEX DEVICE. WHEN REMOVING THE LUNDERGUIST WIRE THERE WAS A LOT OF RESISTANCE, IT IS POSSIBLE THE WIRE GOT STUCK INSIDE THE WIRE PORT OF THE DEVICE, WHEN PULLED HARDER THE DELIVERY SYSTEM INVERTED ITSELF. THE PHYSICIAN REMOVED THIS DEVICE. NO VISIBLE DAMAGE WAS OBSERVED AND ANOTHER THORAFLEX DEVICE WAS IMPLANTED WITHOUT ISSUE. THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00018 TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0151.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21444653 ↗