Thoraflex™ Hybrid THP3032X100BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05037881031750), received between Oct 16, 2025 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 25887429 ↗
• InjuryOct 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  EVENT OF THROMBUS REPORTED FROM EXTEND CLINICAL STUDY (B)(4). SUBJECT: (B)(6), A CAUCASIAN FEMALE AGED 66 (AT THE TIME OF CONSENT TO TRIAL TAKEN ON (B)(6) 2025 UNDERWENT AN ELECTIVE OPEN SURGICAL REPAIR OF THE AORTA WITH A THORAFLEX HYBRID PLEXUS DEVICE ON (B)(6) 2025. INDICATION FOR REPAIR WAS TO TREAT AN AORTIC ANEURYSM. ON POST OPERATIVE DAY 8 (ON (B)(6) 2025), SUBJECT EXPERIENCED SERIOUS ADVERSE EVENT ( SAE) OF THROMBUS - FURTHER DETAILS STATE "THROMBOTIC FORMATIONS DISTAL OF THE FET (FROZEN ELEPHANT TRUNK) PROSTHESIS SHOWN IN CT ON (B)(6) 2025 AT THE THORARC AORTA DESC, THEREFORE, THE DECISION WAS MADE TO PREPONE THE EXTENSION + PERFORM THORACIC ENDOVASCULAR AORTIC REPAIR ( TEVAR) DURING HOSPITALIZATION". THE EVENT WAS CONSIDERED RECOVERED, RESOLVED WITH TREATMENT AND WITHOUT SEQUELAE ON 17-SEP-2025. NO MEDICATION WAS ADMINISTERED TO TREAT THE EVENT. SURGICAL INTERVENTION WAS REQUIRED - PLANNED TEVAR EXTENSION WAS PREPONED AND PERFORMED ON (B)(6) 2025, DURING HOSPITALIZATION. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00086 TO PROVIDE EVENT CLOSURE INFORMATION FOR (B)(4).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23309435 ↗