Thoraflex™ Hybrid THA3034X100ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05037881026947), received between Feb 20, 2024 and Jun 24, 2025 — classified as 1 death, 1 injury.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT WAS REPORTED BY CLINICAL STUDY: EXTEND - (B)(4) ON POST OPERATIVE DAY 30 (B)(6) 2024), A ROUTINE FOLLOW UP CTA C/A/P (THE AUTHOR DEEMS THIS TO BE COMPUTED TOMOGRAPHY ANGIOGRAPHY CHEST/ABDOMEN/PELVIS) REVEALS THERE WAS A FILLING OF THE FALSE LUMEN VIA RE-ENTRY TEARS IN THE DISTAL DESCENDING THORACIC AORTA SHOWING A PARTIAL THROMBOSIS OF FALSE LUMEN IN THE TAA. TREATMENT OF THE EVENT INCLUDED COMPLETION ENDOVASCULAR STENTING OF THE DISTAL DESCENDING THORACIC EVENT. PATIENT UNDERWENT ON (B)(6) 2025, AN ENDOVASCULAR REPAIR OF CHRONIC RESIDUAL DESCENDING DISSECTION DUE TO CONTINUED FILLING OF FALSE LUMEN VIA DISTAL RE-ENTRY TEARS USING A RELAYPRO NBS STENT GRAFT - CATALOGUE NUMBER 28- N4-34-154-3OU, LOT NUMBER: 2405300500, UDI NUMBER: (B)(4). THE PATIENT RECOVERED WITH TREATMENT. THE EVENT WAS CONSIDERED RESOLVED ON 26 MAR 25. THE PATIENT CONTINUED IN THE STUDY. CONCOMITANT MEDICATIONS (TAKEN AT THE TIME OF THE EVENT) INCLUDED: ENALAPRIL (ONGOING) METOPROLOL (ONGOING), WARFARIN WAS STARTED ON (B)(6) 2024 AND IS ONGOING.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22317726 ↗
• DeathFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED EXTEND STUDY: AUTOMATED E-MAIL NOTIFICATION RECEIVED FROM STUDY DATABASE ON 23 JAN 24 REPORTING THE EVENT AORTIC THROMBUS FROM (B)(6) 2023. NO ADDITIONAL DESCRIPTION WAS PROVIDED. THE SITE RECORDED THAT THIS WAS RELATED TO THE THORAFLEX HYBRID DEVICE AND EMAIL CORRESPONDENCE INDICATES THE DEVICE ITSELF HAD NO DEFICIENCIES, AND THERE WAS NO MISPLACEMENT OR MALDEPLOYMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Thrombosis/Thrombus

  MAUDE report 18736770 ↗