Thoraflex™ Hybrid THP3032X150ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05037881026824), received between Jan 14, 2023 and Feb 19, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2024Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  PATIENT PREVIOUSLY HAD OPEN ASCENDING REPAIR AND RELEVANT MEDICAL HISTORY OF DISSECTION. POST OPERATIVE TO THAT PROCEDURE (UK DOS) PATIENT DEVELOPED ADDITIONAL TYPE A DISSECTION AT ANASTOMOSIS LINE AND ADDITIONAL TEAR AT APEX OF THE ARCH. PATIENT SHOWED ON THAT SCAN A COMPRESSED TL WITH THE TL ON THE INNER CURVE OF THE ARCH. DISTAL LANDING ZONE WAS ESTIMATED AT 150MM FROM ZONE 2 WHERE THE SCAN SHOWED THE TLMAX = 29MM AND AORTIC OUTER WALL DIAMETER AVERAGING 36MM. THUS A 30/32/150MM PLEXUS WAS CHOSEN AS THE DEVICE SIZE FOR FET. PATIENT WAS EVALUATED FOR FET/TOTAL ARCH REPAIR WHICH WAS PERFORMED ON (B)(6) 2024 WITH 30/32/150MM PLEXUS CONFIGURATION AT ZONE 2. POST OPERATIVE SCAN FROM (B)(6) 2024 INDICATED GRAFT WAS SEVERELY COMPRESSED IN THE TL. PHYSICIAN IS CONSULTING WITH VASCULAR PARTNER TO CONSIDER ADJUNCTIVE BALLOONING AND/OR FUTURE TEVAR. PATIENT OUTCOME NO CLINICAL SEQUALAE HAS BEEN COMMUNICATED OTHER THAN RADIOLOGIC FINDING OF GRAFT COMPRESSION/COLLAPSE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18729299 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THIS REPORT HAS BEEN SUBMITTED AS A FINAL FOR MFG.REPORT FDA 9612515-2023-00005 TO PROVIDE CORRECTION TO DEVICE DETAILS. UPDATE FROM SITE CONFRIMED THAT THIS WAS NOT A DEVICE RELATED EVENT.

  Patient problems: Stroke/CVA

  MAUDE report 17207067 ↗
• InjuryApr 12, 2023Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE DOCTOR INSERTED THE INVOLVED THORFLEX HYBRID PLEXUS DEVICE INTO THE PATIENT AT THE CONCLUSION OF THE PROCEDURE HE SAID THAT THE TEE STUDY OF THE STENT LOOKED OPEN AND PATENT. THE BRACHIAL PRESSURES MATCHED THE FEMORAL PRESSURES AS WELL. THE DOCTOR ALSO STATED THAT HE DID WELL AND WAS PROGRESSING IN HIS RECOVERY OVER THE WEEKEND. HOWEVER, EITHER SUNDAY OR MONDAY NIGHT Y HIS BRACHIAL PRESSURES DID NOT MATCH THE FEMORAL AND HIS HEALTH STARTED TO DECLINE. A CT SCAN WAS DONE AT THAT TIME AND SHOWED COMPRESSION OF THE STENT GRAFT PORTION OF THE THORAFLEX. THERE IS A FOLLOW UP PROCEDURE SCHEDULED FOR 15 MAR 2023 TO ADDRESS THE STENT COMPRESSION. ADDITIONAL INFORMATION WAS RECEIVED ON RELEVANT MEDICAL CONDITIONS.TYPE A AND TYPE B DISSECTION WITH PREVIOUS ASCENDING HEMIARCH REPAIR AND A THORACO ABDOMINAL GRAFT. PHYSICIAN'S OPINION FOR CAUSE OF THIS EVENT WAS POSSIBILITY THE DEVICE NOT THE PROCEDURE AND PRE-EXISTING CONDITION, YES. PATIENT OUTCOME WAS PATIENT WAS IN THE HOSPITAL AND INTUBATED.

  Patient problems: Diminished Pulse Pressure

  MAUDE report 16722372 ↗
• InjuryJan 14, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED FROM PANTHER STUDY FOR RETROSPECTIVE PATIENT. ON (B)(6) 2019 PATIENT WAS IMPLANTED WITH GELWEAVE EXTRA LONG BIFURCATE IN THE MESENTERIC ARTERY TO TREAT CHRONIC MESENTERIC ISCHEMIA. THROMBOSIS IN DEVICE WAS IDENTIFIED ON (B)(6) 2020. ADVERSE EVENT WAS REPORTED AS RELATED TO THE DEVICE AND PRE-EXISTING CONDITION NOT RELATED TO PROCEDURE AND OUTCOME IS ONGOING. NO ACTION WAS TAKEN TO TREAT THE EVENT.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 16166721 ↗