Thoraflex™ Hybrid THA3038X150ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05037881027067), received between Apr 3, 2024 and Feb 14, 2025 — classified as 2 deaths.

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.

• DeathFeb 14, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IMPLANT DATE : (B)(6) 2023. EVENT WAS REPORTED FROM EXTEND POST MARKET STUDY (B)(6)) AS ARTERIAL CLOTS.

  Patient problems: Coronary obstruction/occlusion

  MAUDE report 21383080 ↗
• DeathApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AUTOMATED E-MAIL NOTIFICATION RECEIVED FROM STUDY DATABASE ON 08 FEB 2024 REPORTING THE EVENT OF CVA (STROKE) FROM 31 JAN 24. AT THE TIME OF REPORTING THE "RELATIONSHIP TO DEVICE WAS NOT COMPLETED" HOWEVER AN EMAIL NOTIFICATION WAS RECEIVED ON 15 MAR 2024 WHERE THE "RELATIONSHIP TO DEVICE" HAD BEEN POPULATED AS "POSSIBLY RELATED". # INFORMATION PROVIDED FROM SITE WAS -CTA SHOWED RIGHT M1/M2 OCCLUSION AND CTP SHOWING PERFUSION DEFICIT. THE SUBJECT DIED ON (B)(6) 2024. AN EXPORT OF THE INFORMATION AVAILABLE IN THE STUDY DATABASE FOR THIS SUBJECT TO DATE HAS BEEN PROVIDED SEPARATELY. PATIENT (B)(6) WAS NOTED TO HAVE AN ENDOLEAK AND ON (B)(6) 2024 WENT TO THE OPERATING ROOM WITH DR. (B)(6) ASCENDING AORTIC, TOTAL ARCH REPLACEMENT, AORTIC VALVE RESUSPENSION, FROZEN ELEPHANT TRUNK WITH THORAFLEX GRAFT, CABG X2, LIMA-LAD, SVG-OM, MV REPAIR WITH TRIANGULAR RESECTION OF P2 SEGMENT, PHYSIO II RING, INTRAOPERATIVELY FOUND TO HAVE LOST LEFT SIDED SSEPS CONSISTENT WITH A RT. CORTICAL PROCESS. ON SUBSEQUENT NEUROIMAGING FOUND TO HAVE A RT. M1 OCCLUSION, S/P EVT WITH SMAT X 1 VIA DIRECT CAROTID ACCESS WITH TICI3 REPERFUSION. POST OPERATIVE COURSE COMPLICATED BY HEMORRHAGIC CONVERSION OF CVA WITH

  Patient problems: Stroke/CVA

  MAUDE report 19030289 ↗