Thoraflex™ Hybrid THP3036X100ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05037881026749), received between Nov 14, 2024 and Nov 17, 2025 — classified as 5 injuries, 2 malfunctions.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  EVENT REPORTED FORM EXTEND STUDY (B)(6) ON POST-OPERATIVE DAY 13, SUBJECT EXPERIENCED AN SERIOUS ADVERSE EVENT OF PSEUDOANEURYSM BRACIOCEPHALIC ARTERY. NO MEDICATION WAS GIVEN TO TREAT THE EVENT. SURGICAL INTERVENTION WAS REQUIRED - SITE DETAILS "PERSISTENT FALSE LUMEN FLOW ENLARGEMENT, PROXIMAL DESCENDING THORACIC AORTA INDETERMINATE SOURCE OF PROXIMAL FALSE LUMEN FLOW/FALSE LUMEN EMBOLIZATION PROXIMAL DESCENDING AORTA". THE EVENT WAS CONSIDERED RECOVERED, RESOLVED WITH TREATMENT AND RESOLVED WITHOUT SEQUELAE ON (B)(6) 2025. SUBJECT CONTINUES ON THE STUDY. SURGICAL INTERVENTION - FALSE LUMEN EMBOLIZATION. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00093 TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0345.

  Patient problems: Pseudoaneurysm

  MAUDE report 23569013 ↗
• InjuryNov 17, 2025Device Endoleak; Device Endoleak

  EVENT WAS REPORTED BY EXTEND STUDY - (B)(6). EVENT REPORTED AS ENDOLEAK TYPE 3; THE SITE ORIGINALLY RECORDED THE EVENT OF ENDOLEAK IN THE STUDY DATABASE ON (B)(6) 2025. THE AE DESCRIPTION OF "ENDOLEAK TYPE III" WAS ADDED ON (B)(6) 2025, AS WAS THE DEVICE RELATIONSHIP OF "POSSIBLY RELATED" AND CONFIRMATION THAT THE EVENT WAS ASSOCIATED WITH A DEVICE DEFICIENCY. THE FOLLOWING ADDITIONAL DETAILS WERE INCLUDED ON THE ADVERSE EVENT FORM "PERSISTENT FALSE LUMEN FLOW WITH ENLARGEMENT OF THE PROXIMAL DESCENDING THORACIC AORTA. 3. APPARENT TYPE 3 ENDOLEAK THROUGH THE PROXIMAL AORTIC ENDOGRAFT (THORAFLEX)." PLEASE NOTE THAT THE SITE HAVE YET TO COMPLETE THE DEVICE DEFICIENCY FORM IN THE DATABASE. AS PER PROVIDED SOURCE NOTES "PATIENT RECENTLY UNDERWENT EMBOLIZATION COILING OF A POTENTIAL TYPE III ENDOLEAK." THIS REPORT IS BEING SUBMITTED AS FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00092 TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0343.

  Patient problems: Chest Pain; Clinical Endoleak

  MAUDE report 23568968 ↗
• InjuryNov 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  EVENT OF RIGHT LOWER POLE RENAL INFARCT REPORTED FROM EXTEND STUDY (B)(6). A CAUCASIAN MALE SUBJECT UNDERWENT AN EMERGENT (WITHIN 24HRS) OPEN SURGICAL REPAIR OF THE AORTA WITH A THORAFLEX HYBRID PLEXUS DEVICE ON (B)(6) 2025. INDICATION FOR REPAIR WAS TO TREAT HYPERACUTE DEBAKEY TYPE II DISSECTION OF THE AORTA. ON POST-OPERATIVE DAY 2 ((B)(6) 2025), SUBJECT (B)(6) EXPERIENCED AN AE OF RIGHT LOWER POLE RENAL INFARCT. FURTHER DETAILS STATE, "SEQUELA OF RENAL INFARCT IN THE RIGHT LOWER POLE". ADVERSE EVENT OUTCOME WAS CONSIDERED UNKNOWN AT TIME OF REPORTING. NO MEDICATION WAS GIVEN TO TREAT THE EVENT. NO SURGICAL INTERVENTION WAS REQUIRED. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0340.

  Patient problems: Renal Impairment

  MAUDE report 23461823 ↗
• MalfunctionMay 13, 2025Material Fragmentation; Material Fragmentation

  DURING DEPLOYMENT, AS PHYSICIAN WAS PULLING ON RED CLIP TO REMOVE IT FROM THE DELIVERY SYSTEM, A PIECE OF THE RED CLIP BROKE OFF AND FELL INTO THE PATIENT'S OPEN CHEST. THE SURGEON STOPPED THE PROCEDURE TO EXPLORE THE CHEST CAVITY, LOCATE THE PIECE OF BROKEN PLASTIC AND RETRIEVE IT. THORAFLEX DEVICE DEPLOYED WITHOUT FURTHER INCIDENT OR NEGATIVE IMPACT ON THE PATIENT OR PROCEDURE. THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER: 9612515-2025-00051 TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0223.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22008400 ↗
• InjuryMar 25, 2025Obstruction of Flow; Obstruction of Flow

  ON POST OPERATIVE DAY 0 (B)(6) 2024), THE PATIENT EXPERIENCED A SERIOUS ADVERSE EVENT (SAE)OF FEMORAL ARTERY THROMBUS, FURTHER COMMENTARY STATES THE FLOW OF THE LEFT LEG BEYOND THE FEMORAL ARTERY CANNULATION SITE HAD A WEAK SIGNAL'. TREATMENT OF THE EVENT INCLUDED VASCULAR SURGERY - A THROMBECTOMY AND REPAIR OF THE FEMORAL ARTERY WAS PERFORMED. THE EVENT WAS CONSIDERED RESOLVED ON POST-OP DAY 0 AND THE PATIENT CONTINUED IN THE STUDY. CONCOMITANT MEDICATIONS (TAKEN AT THE TIME OF THE EVENT) INCLUDED ASPIRIN 81MG, WARFARIN 1MG, ENOXAPARIN SODIUM AND HEPARIN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21686992 ↗
• InjuryMar 25, 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) PATIENT NO. (B)(6), ON POST OPERATIVE DAY 6 (B)(6) 2024 A COMPUTED TOMOGRAPHY SCAN SHOWED THERE IS A NEW LUCENCY INVOLVING THE LEFT SUPERIOR CEREBELLUM, COMPATIBLE WITH NEW AREA OF ACUTE ISCHAEMIA. TREATMENT OF THE EVENT INCLUDED PHYSICAL AND OCCUPATIONAL THERAPY. THE EVENT WAS CONSIDERED UNRESOLVED AT THE TIME OF THIS REPORT. THE PATIENT CONTINUED IN THE STUDY. CONCOMITANT MEDICATIONS INCLUDED (TAKEN AT THE TIME OF THE EVENT): ASPIRIN 81MG (ONGOING), WARFARIN 1MG TABLET (ONGOING), ENOXAPARIN SODIUM (ONGOING), METOPROLOL: START DATE (B)(6) 2024 - ONGOING. THE CLINICAL EVENTS COMMITTEE (CEC) ADJUDICATED THAT THE EVENT WAS POSSIBLY RELATED TO THE THORAFLEX HYBRID DEVICE AND THE PROCEDURE. NOTE: (B)(4) WAS INITIALLY RAISED FOR STROKE AND DEEMED NOT DEVICE RELATED. HOWEVER, THE CLINICAL EVENTS COMMITTEE (CEC) HAS NOW CONSIDERED THE EVENT TO BE POSSIBLY DEVICE RELATED. THEREFORE, THE EVENT HAS BEEN RAISED AGAIN. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00031 TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0200.

  Patient problems: Stroke/CVA

  MAUDE report 21686944 ↗
• MalfunctionNov 14, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AFTER DEPLOYMENT OF THE THORAFLEX HYBRID DEVICE, AND RESTORING FLOW, NO FLOW WAS GETTING DISTAL TO THE THORAFLEX. IT WAS DECIDED TO BALLOON THE ENDOGRAFT PORTION OF THE THORAFLEX. AFTER BALLOONING, FLOW WAS ACHIEVED. THIS REPORT IS BEING SUBMITED AS A FINAL FOR MFG REPORT NUMBER TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0068.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20682537 ↗