Thoraflex™ Hybrid THA3034X150ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05037881027043), received between Aug 28, 2024 and Jun 27, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  EVENT NAME: AORTIC PSEUDOCOARCTATION. EXTEND-001 (B)(6), PATIENT NO. (B)(6) ON POST-OPERATIVE DAY 2 (B)(6) 2025), AORTIC PSEUDOCOARCTATION AT THE JUNCTION BETWEEN THE STENT GRAFT FOR THE THORAFLEX AND THE DACRON COMPONENT NOTED ON CHEST COMPUTED TOMOGRAPHY SCAN. TREATMENT OF THE EVENT WAS SURGICAL PATIENT UNDERWENT BALLOON ANGIOPLASTY ON (B)(6) 2025. THE SERIOUS ADVERSE EVENT (SAE) WAS CONSIDERED SEVERE. THE SAE IS RESOLVED WITH TREATMENT, AND RESOLVED WITHOUT SEQUELAE. SUBJECT CONTINUES IN THE STUDY.

  Patient problems: Insufficient Information; Reduced Blood Flow

  MAUDE report 22343903 ↗
• MalfunctionMar 12, 2025Material Integrity Problem; Material Integrity Problem

  LEAKAGE FROM A THORAFLEX HYBRID ANTE-FLO FROM THE SUTURE LINE CONNECTING THE CUFF TO THE MAIN BODY - GREEN SUTURE LINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21582557 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL TRIAL: EXTEND-001 (B)(4). THORAFLEX HYBRID WAS IMPLANTED ON (B)(6) 2023. NO DISTAL SEAL WAS INTENDED DUE TO A PLANNED EVAR (UNDERSTOOD TO BE ENDOVASCULAR AORTIC REPAIR) EXTENSION AND NO DISTAL SEAL WAS OBTAINED. NO ENDOLEAK WAS PRESENT AT THE END OF THE PROCEDURE. DELIVERY OF THE THORAFLEX HYBRID WAS SUCCESSFUL, DEPLOYED IN PLANNED LOCATION AND WITHDRAWAL OF DELIVERY SYSTEM WAS SUCCESSFUL. NO DEVICE DEFICIENCIES OCCURRED DURING THE INDEX TH (UNDERSTOOD TO BE THORAFLEX HYBRID) PROCEDURE. EVENT DETAILS - RUPTURE (ONSET DATE 17-JUL-24, RESOLVED ON (B)(6) 2024). CONTAINED RUPTURE OF THE DESCENDING THORACIC AORTA DISTAL TO PREVIOUS ENDOVASCULAR AORTIC REPAIR. THE CLINICIAN/SITE HAVE REPORTED THIS EVENT AS NOT RELATED TO PROCEDURE AND NOT RELATED TO DEVICE. DURING THEIR REGULAR REVIEW OF EXTEND ADVERSE EVENTS, THE STUDY MEDICAL MONITOR HAS REVIEWED AND MARKED THIS EVENT AS POSSIBLY RELATED TO THE DEVICE. SURGICAL PROCEDURE CARRIED OUT - TEVAR ON (B)(6) 2024. TERUMO CATALOGUE NUMBER 2312050409. OUTCOME OF EVENT HAS BEEN RECORDED AS RESOLVED WITH TREATMENT.

  Patient problems: Rupture

  MAUDE report 20083291 ↗