Thoraflex™ Hybrid THP3036X150ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05037881026848), received between Jun 18, 2024 and Aug 18, 2025 — classified as 1 death, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathAug 18, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT WAS ADMITTED ON (B)(6) 2024 AND DIED ON (B)(6) 2024. CAUSE OF DEATH IS CURRENTLY UNKNOWN.

  Patient problems: Insufficient Information; Multiple Organ Dysfunction Syndrome; Obstruction/Occlusion

  MAUDE report 22828025 ↗
• InjuryApr 9, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  EXTEND-001 (NCT05639400), SITE NO. (B)(4): ON POST OP DAY 1 SEDATION WAS WEANED OFF AND DID NOT WAKE UP AND WAS TAKEN FOR A HEAD CT SCAN WHICH DEMONSTRATED A RIGHT M2 OCCLUSION WITH EXTENSIVE INFARCT IN THE RIGHT MCA (MIDDLE CEREBRAL ARTERY), RIGHT PCA (POSTERIOR CEREBRAL ARTERY) AND RIGHT ACA (ANTERIOR CEREBRAL ARTERY) TERRITORIES. THE PATIENT CONDITION WORSENED ON POST OP DAY 5 AND WAS TAKEN FOR A REPEAT HCT (HEAD COMPUTED TOMOGRAPHY) SHOWING NEW MASS EFFECT OF THE RIGHT VENTRICLES AND EFFACEMENT WITH MIDLINE SHIFT FROM RIGHT TO LEFT WITH CONCERN FOR HERNIATION. NEUROSURGERY RECOMMENDED TO CONTINUE WITH MEDICAL MANAGEMENT. ON POST OPERATIVE DAY ONE (B)(6)2024), THE PATIENT HAD A SLOW EMERGENCE FROM SEDATION WEAN FOUND TO HAVE STROKES IN RIGHT MCA. HCT DEMONSTRATED "PROXIMAL RIGHT M2 MCA ANTERIOR DIVISION LARGE VESSEL OCCLUSION WITH INFARCT IN THE RIGHT MCA, PCA AND ACA TERRITORIES. MRS (MODIFIED RANKIN SCORE) ON (B)(6) 2024 WAS DOCUMENTED AS 0 (NO SYMPTOMS AT ALL). MRS ON (B)(6) 2024 (32 DAYS POST PROCEDURE) WAS 5 (SEVERE DISABILITY, BEDRIDDEN, INCONTINENT, REQUIRING CONSTANT NURSING CARE AND ATTENTION). SPINAL CORD ISCHAEMIA GUIDE ON (B)(6)2024 (32 DAYS POST PROCEDURE) WAS 3B (N

  Patient problems: Stroke/CVA

  MAUDE report 21805167 ↗
• InjuryJun 18, 2024Device Endoleak; Device Endoleak

  AS REPORTED BY THE EXTEND-001 STUDY: IMPLANT DATE WAS (B)(6)2024, EVENT DATE WAS 16 MAY 24. EVENT REPORTED AS ENDOLEAK THROUGH THE EXISTING THORACIC ENDOVASCULAR AORTIC DEVICES. THORACIC ENDOVASCULAR AORTIC ANEURYSM REPAIR NOT INVOLVING LT SUBCLAVIAN ARTERY RELINES THE EXISTING DEVICES AND EXTEND TO TREAT THE POOR TRUE LUMEN EXPANSION IN THE DISTAL DESCENDING THORACIC AORTA. SURGICAL INTERVENTION WAS MARKED AS REQUIRED, BUT NO CONFIRMATION OF WHAT INTERVENTION WAS PERFORMED. PATIENT PRE-EXISTING CONDITIONS: HYPERTENSION, TYPE 2 DIABETES, ERECTILE DYSFUNCTION, AND PREVIOUS EMERGENT TYPE A DISSECTION REPAIR ASCENDING AORTA REPLACEMENT. THIS EVENT OCCURRED AFTER PROCEDURE AND THE PERIOD OF THE EVENT OCCURRED FOR 36 DAYS. THIS EVENT HAS BEEN MARKED AS DEVICE RELATED (WITHOUT DEVICE DEFICIENCY DESCRIPTION), POSSIBLY PROCEDURE RELATED AND NO INFORMATION IF IS RELATED TO PATIENT PREEXISTING CONDITION. PATIENT RECOVERED AND RESOLVED WITH TREATMENT ON (B)(6) 2024.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 19556172 ↗