Thoraflex™ Hybrid THP2224X100BRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05037881031712), received between Jul 15, 2026 and Jul 21, 2026 — classified as 3 injuries.

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.

• InjuryJul 21, 2026Insufficient Device Problem Information

  EVENTS REPORTED FROM INSEL GRUPPE AG - 3064, VIA SWISSMEDIC REPORT. EVENTS REPORTED AS THROMBUS AFTER FROZEN ELEPHANT TRUNK. THROMBUS AT THE DISTAL STENT END OF THE FROZEN ELEPHANT TRUNK IS A WELL-KNOWN COMPLICATION. IN THE LITERATURE, THE INCIDENCE IS GIVEN AS ABOUT 8-16%. RECENTLY, WE HAVE HAD THE IMPRESSION THAT THIS COMPLICATION IS OCCURRING MORE OFTEN IN OUR COUNTRY. THE SITE COMPILED THE CASES OF THE LAST THREE MONTHS, IT WAS FOUND THAT 5 OUT OF 12 PATIENTS HAD A DISTAL THROMBUS, WHICH IS SIGNIFICANTLY HIGHER THAN THE RATE DESCRIBED IN THE LITERATURE. THIS IS SIGNIFICANTLY HIGHER THAN THE RATE DESCRIBED IN THE LITERATURE. IN ADDITION, THERE WAS A CASE WITH SERIOUS CLINICAL CONSEQUENCES LAST NOVEMBER. DESPITE CAREFUL INTRA-OPERATIVE MEASURES AND ESTABLISHED AVOIDANCE STRATEGIES ON OUR PART, THROMBI FORMATION CONTINUES TO OCCUR, WHICH IS WHY WE WOULD LIKE TO REPORT THIS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25887392 ↗
• InjuryJul 16, 2026Adverse Event Without Identified Device or Use Problem

  EVENT REPORTED BY THOR - (B)(4). PATIENT (B)(6), A WHITE MALE WITH AORTIC CHRONIC DISSECTION, EXPERIENCED AN EVENT OF DSINE (DISTAL STENT GRAFT INDUCED NEW ENTRY). THE PATIENT UNDERWENT AN OPEN SURGICAL REPLACEMENT OF THE AORTA WITH A THORAFLEX HYBRID PLEXUS DEVICE ON (B)(6) 2021. ON POST OPERATIVE DAY 369 ((B)(6)2022), PATIENT (B)(6) HAD AN AE (ADVERSE EVENT) OF DSINE (ON CT SCAN FROM (B)(6) 2022 WAS A DSINE DETECTABLE). TREATMENT OF THIS AE INCLUDED REINTERVENTION, TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR) -IMPLANTATION ON (B)(6) 2022. THE AE WAS CONSIDERED RESOLVED ON (B)(6) 2022 AND THE PATIENT CONTINUED IN THE STUDY.

  Patient problems: Aortic dissection

  MAUDE report 25835011 ↗
• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  EVENT REPORTED BY THOR - (B)(4). PATIENT 027, A WHITE FEMALE WITH AORTIC CHRONIC DISSECTION, EXPERIENCED AN EVENT OF DSINE( DISTAL STENT GRAFT INDUCED NEW ENTRY). THE PATIENT UNDERWENT AN OPEN SURGICAL REPLACEMENT OF THE AORTA WITH A THORAFLEX HYBRID PLEXUS DEVICE ON (B)(6) 21. ON POST OPERATIVE DAY 384 ((B)(6) 22), PATIENT 027 HAD AN AE(ADVERSE EVENT) OF DSINE (ON CT SCAN FROM (B)(6).2022 WAS A DSINE DETECTABLE). TREATMENT OF THIS AE INCLUDED REINTERVENTION, TEVAR(THORACIC ENDOVASCULAR AORTIC REPAIR) -IMPLANTATION ON (B)(6) 23. THE EVENT WAS CONSIDERED RESOLVED ON 11-MAY-23 AND THE PATIENT CONTINUED IN THE STUDY.

  Patient problems: Aortic dissection

  MAUDE report 25824770 ↗