Thoraflex™ Hybrid THP2830X100BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05037881031743), received between Jul 21, 2026 and Jul 21, 2026 — classified as 2 injuries.

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.

• 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 25887462 ↗
• 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 25887446 ↗