Thoraflex™ Hybrid THP3038X100ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05037881026756), received between May 8, 2024 and Mar 4, 2025 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathMar 4, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  DOCTOR WAS UNABLE TO CONTROL BLEEDING AT THE PROXIMAL END OF THE AORTA DUE TO CONTINUOUS FILLING OF THE FALSE LUMEN. AS AN ATTEMPT TO REGAIN CONTROL, AT RELAY PRO WAS DEPLOYED TO ELIMINATE THE DISTAL PREFUSION OF THE FALSE LUMEN. THE RELAY PRO WAS SUCCESSFULLY DEPLOYED AND SUCCESSFULLY COVERED THE FENESTRATIONS WITHIN ITS LENGTH. ADDITIONAL FENESTRATIONS WERE NOTED DISTAL TO THE RELAY GRAFT THAT WERE STILL FILLING THE FALSE LUMEN. IT IS BELIEVED THAT THIS LED TO THE BLEEDING THAT COULD NO LONGER BE CONTROLLED PROXIMALLY. PATIENT OUTCOME: THE PATIENT DID NOT SURVIVE THE SURGERY. AFTER SPEAKING WITH DOCTOR, THEY WERE NOT LEFT WITH THE IMPRESSION THAT THE DEVICE DID NOT HAVE A ROLE IN THE OUTCOME. IT WAS MENTIONED THAT HE SIMPLY WAS UNABLE TO CONTROL/STOP THE BLEEDING. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00019 TO PROVIDE EVENT CLOSURE INFORMATION FOR (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21512465 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AUTOMATED E-MAIL NOTIFICATION RECEIVED FROM STUDY DATABASE ON 10 APR 2024 REPORTING THE EVENT OF DESCENDING AORTIC ANEURYSM FROM 02 APR 24. FURTHER INFORMATION RELATED TO THIS COMPLAINT WAS PRESENTED ON 25 APR 24 WHICH DESCRIBED THAT SURGICAL FINDINGS INCLUDE A D-SINE (DISTAL STENT GRAFT-INDUCED NEW ENTRY) AT THE END OF THE STENT GRAFT. IMPLANTATION OF THE DEVICE WAS ON 19 OCT 23. PATIENT OUTCOME: PATIENT HAS HAD A THORACOTOMY WITH RESECTION AND GRAFT REPLACEMENT OF DESCENDING THORACIC ANEURYSM. A SECONDARY INTERVENTION WAS PERFORMED ON 08 APR 24, WHICH INVOLVED A LEFT POSTEROLATERAL THORACOTOMY FOR RESECTION AND REPLACEMENT OF DESCENDING THORACIC AORTA WITH 32 MM SIENNA GRAFT (PROXIMAL ANASTOMOSIS AT THE DISTAL END OF PREVIOUS THORAFLEX GRAFT, DISTAL ANASTOMOSIS JUST ABOVE THE DIAPHRAGM). THE EVENT AND TREATMENT ARE ONGOING.

  Patient problems: Aneurysm

  MAUDE report 19266442 ↗