Thoraflex™ Hybrid THP3032X100ARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05037881026725), received between Nov 11, 2022 and Sep 12, 2025 — classified as 3 deaths, 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  CLINICAL TRIAL EXTEND-001 (B)(4), ON POST-OPERATIVE DAY 2 (ON (B)(6) 2023), SUBJECT (B)(6) EXPERIENCED AN ADVERSE EVENT OF LEFT CAROTID ARTERY THROMBUS STATUS POST LEFT CAROTID CUTDOWN. THE EVENT WAS CONSIDERED RECOVERED, RESOLVED WITH TREATMENT AND RESOLVED WITHOUT SEQUELAE ON 28-MAY-2023. NO MEDICATION WAS GIVEN TO TREAT THE EVENT. SURGICAL INTERVENTION WAS REQUIRED -THROMBECTOMY, STENT PLACEMENT AND CUTDOWN PROCEDURE. SUBJECT CONTINUES ON THE STUDY. THIS REPORT IS BEING SUBMITTED AS FINAL FOR MANUFACTURING REPORT NUMBER: 9612515-2025-00079 TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0309.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23035527 ↗
• DeathAug 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  EVENT OF ISCHAEMIC RIGHT FOOT REPORTED FORM THE EXTEND STUDY (B)(6). SUBJECT (B)(6), A CAUCASIAN MALE AGED 77 AT TIME OF CONSENT (TAKEN (B)(6) 2025), UNDERWENT AN ELECTIVE OPEN SURGICAL REPAIR OF THE AORTA WITH A THORAFLEX HYBRID, ON POST-OPERATIVE DAY 40 ((B)(6) 2025), SUBJECT (B)(6) EXPERIENCED AN ADVERSE EVENT OF ISCHAEMIC RIGHT FOOT, FURTHER DETAILS STATING, "REDUCED BLOOD SUPPLY TO THE FOOT". TREATMENT OF EVENT INCLUDED MEDICATION (MEDICATION UNCONFIRMED). IT IS UNKNOWN AT TIME OF REPORTING IF THE EVENT IS ONGOING. INVESTIGATOR CONSIDERED THE EVENT UNANTICIPATED AND SEVERE IN NATURE. EVENT WAS CONSIDERED RELATED TO PROCEDURE, POSSIBLY RELATED TO DEVICE, NOT RELATED TO A DEVICE DEFICIENCY/FAILURE, AND POSSIBLY RELATED TO A PRE-EXISTING CONDITION.

  Patient problems: Ischemia

  MAUDE report 22859478 ↗
• InjuryJul 15, 2025Obstruction of Flow; Obstruction of Flow

  EVENT NAME: NON-OCCLUSIVE LEFT SUBCLAVIAN ARTERY THROMBUS. EXTEND-001 (NCT05639400) STUDY, PATIENT NO. (B)(6), ON POST OPERATIVE DAY 8 (B)(6) 2025), SITE REPORTED AN ADVERSE EVENT (AE) OF NON-OCCLUSIVE LEFT SUBCLAVIAN ARTERY THROMBUS. DUAL ANTIPLATELET THERAPY WAS CONTINUED. THE AE WAS CONSIDERED MILD IN SEVERITY AND RELATED TO THE PROCEDURE. AT TIME OF REPORTING, THE EVENT IS STILL ONGOING, WITH CURRENT STATUS UNRESOLVED STILL TREATING. SUBJECT CONTINUES ON THE STUDY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22504951 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THIS EVENT WAS REPORTED AS PART OF THE EXTEND-001 CLINICAL STUDY (B)(6). PATIENT'S INITIAL THORAFLEX HYBRID IMPLANT TOOK PLACE ON (B)(6) 2025. ON (B)(6) 2025 PATIENT UNDERWENT AN EXTENSION PROCEDURE WITH RELAYPRONBS AND GORE VIABAHN ENDOPROSTHESIS. DURING THE EXTENSION PROCEDURE THE PATIENT HAD AN ADVERSE EVENT OF PERICARDIAL EFFUSION. THE SITE PROVIDED THE FOLLOWING NARRATIVE: "MODERATE TO LARGE PERICARDIAL EFFUSION SEEN DURING EXTENSION IMPLANT, DRAINED INTRA-OPERATIVELY AND MEDIASTINAL DRAIN PLACED. DRAIN REMOVED 5/13." PROCEDURE CARRIED OUT AS A RESULT OF THE EVENT WAS INTRA-OPERATIVE DRAINAGE OF THE PERICARDIAL EFFUSION.

  Patient problems: Pericardial Effusion

  MAUDE report 22468398 ↗
• InjuryMay 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  EVENT OF THROMBUS ON THE MEDIAL CURVE OF ARCH AFTER IMPLANTING A THP3032X100A THORAFLEX HYBRID DEVICE ON A PATIENT REQUIRING AN FET (UNDERSTOOD TO BE A FROZEN ELEPHANT TRUNK) PHYSICIANS HAVE ADMINISTERED ANTICOAGULANTS. PATIENT OUTCOME IS UNKNOWN AT THIS TIME.

  Patient problems: Ischemia; Thrombosis/Thrombus

  MAUDE report 22094756 ↗
• InjuryJan 29, 2025Deformation Due to Compressive Stress; Device Endoleak; Deformation Due to Compressive Stress; Device Endoleak

  THE PATIENT WAS ADMITTED TO OUTSIDE HOSPITAL ON (B)(6)2024 WITH LEFT SIDED HEMIPLEGIA AND SENSORY CHANGE. PATIENT WAS TREATED WITH MECHANICAL THROMBECTOMY ON (B)(6)2024 AND WAS FOUND TO HAVE THROMBUS AT THE BRANCH OF RIGHT INNOMINATE ARTERY. INVESTIGATOR ASSESSMENT OF POSSIBLY RELATED TO DEVICE, UNDETERMINED IF RELATED TO THORAFLEX HYBRID OR RELAYPRO NBS SPECIFICALLY. THE PATIENT OUTCOME WAS RESOLVED ON (B)(6)2024. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00009 TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0134.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 21263125 ↗
• DeathNov 21, 2022Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE INVOLVED WIRE WAS NOT REMOVED PRIOR TO PULLING THE RED TAB CAUSING THE STENT GRAFT TO ACCORDION AND LOSE THE DISTAL SEAL WHICH LED TO BLEEDING. THE DEVICE WAS FOUND TO BE BUNCHED UP IN THE DESCENDING AORTA. THE DEVICE WAS PUSHED OUT AND EXTENDED WITH A GORE TAG DEVICE. PATIENT DECEASED SIX (6) DAYS POST OPERATION, CAUSE OF DEATH WAS A STROKE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15838735 ↗
• DeathNov 11, 2022Device Handling Problem; Device Handling Problem

  ON THE (B)(6) 2022 THORAFLEX HYBRID IMPLANT WAS CARRIED OUT. DURING PROCEDURE WIRE WAS NOT REMOVED PRIOR TO PULLING RED TAB CAUSING STENT GRAFT TO "ACCORDION" AND LOSS OF DISTAL SEAL LEADING TO BLEEDING. STENTED SECTION OF THE DEVICE WAS FOUND TO BE BUNCHED UP IN THE DESCENDING AORTA. DEVICE PUSHED OUT AND EXTENDED WITH GORE TAG DEVICE. SIX DAYS POST PROCEDURE PATIENT DECEASED DUE TO STROKE.

  Patient problems: Stroke/CVA

  MAUDE report 15779818 ↗