Thoraflex™ Hybrid THA3032X150ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05037881027036), received between Nov 1, 2023 and May 19, 2025 — classified as 2 deaths, 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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.

• DeathMay 19, 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 DATE: 04 APR 2025. IMPLANT DATE: ON (B)(6) 2025. EVENT REPORTED FROM EXTEND STUDY: (B)(4) (SITE: (B)(4) FOR PATIENT (B)(6). FIRST EVENT OF CARDIAC ARREST ON POST OPERATIVE DAY 0 (ON (B)(6) 2025), SITE REPORTED A SERIOUS ADVERSE EVENT (SAE) OF CARDIAC ARREST - FURTHER COMMENTS DETAIL "PATIENT CODED POST-OPERATIVELY IN THE ICU". SECOND EVENT ON POST OPERATIVE DAY 0 (ON (B)(6) 2025), SITE REPORTED A SERIOUS ADVERSE EVENT (SAE) OF STROKE, ANOXIC BRAIN INJURY - FURTHER COMMENTS DETAIL "BILATERAL, MULTIFOCAL POSTERIOR CIRCULATION STROKES, ANOXIC BRAIN INJURY POST-CARDIAC ARREST". CARDIAC ARREST OCCURRED POST-OPERATIVELY ON (B)(6) 2025, AS DETAILED IN SEPARATE EVENT INTAKE FORM. THIRD EVENT ON POST OPERATIVE DAY 16 (ON (B)(6) 2025), SITE REPORTED A SERIOUS ADVERSE EVENT (SAE) OF CARDIOPULMONARY ARREST - FURTHER COMMENTS DETAIL "CARDIOPULMONARY ARREST DUE TO ANOXIC BRAIN INJURY AND RESPIRATORY INSUFFICIENCY. PATIENT HAD BEEN MOVED TO PALLIATIVE CARE AND MADE DNR (DO NOT RESUSCITATE)". THERE WAS NO DEVICE FAILURE/DEFICIENCY REPORTED. SAE NOTED AS ONGOING AT TIME OF REPORTING, BUT SUBSEQUENT SAE DETAILS SUBJECT OUTCOME OF DEATH ON (B)(6) 2025.

  Patient problems: Cardiac Arrest; Kidney injury; Stroke/CVA

  MAUDE report 22042527 ↗
• DeathApr 9, 2025Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  EVENT TYPE: ACUTE DISSECTION. THE ISSUE WAS IDENTIFIED AS IMPROPER PLACEMENT OF THE DEVICE RATHER THAN A DEVICE FAILURE. SURGICAL INTERVENTION: ENDOVASCULAR REPAIR WAS RECOMMENDED AND COMPLETED. OUTCOME: PATIENT IS DOING WELL.

  Patient problems: Aortic dissection

  MAUDE report 21805267 ↗
• InjuryNov 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CLINICIAN NOTICED THAT THE GRAFTS WAS PULSING BLOOD AT THE ANASTOMOSIS OF THE STENT AND SURGICAL GRAFT. HE SAYS THAT IT APPEARS TO BE COMING FROM THE GREEN SUTURE LINE THAT CONNECTS THE STENT, GRAFT AND SKIRT. HE CHOSE TO LEAVE THE PATIENT [?]OPEN' OVERNIGHT TO SEE IF IT WOULD RESOLVE ON ITS OWN AND IT DID. HE WAS CONCERNED WITH THE BLEEDING AS HE NEVER HAD THIS OCCUR BEFORE WITH THIS DEVICE. HE HAS IMPLANTS 6-7 THORAFLEX SO FAR AND HAS NOT EXPERIENCED THIS. THE CLINICIAN REPORTING THIS OCCURRENCE TO SEE IF THIS CAN BE INVESTIGATED TO SEE IF A ROOT CAUSE CAN BE IDENTIFIED AND CORRECTED. ADDITIONAL INFORMATION WAS RECEIVED ON 22 NOV 23 FROM SITE THAT CONFIRMED THE GRAFT WAS NOT PRE-SOAKED PRIOR TO USE. IN THE THORAFLEX HYBRID US IFU (301-213-USEN) IT STATE [?]S TO SOAK THE GRAFT FOR 5 MINUTES ON APPROXIMATELY 700ML OF SALINE SOLUTION THIS REPORT IS BEING SUBMITTED AS FINAL FOR MFG REPORT #9612515-2023-00028 TO PROVIDE EVENT CLOSURE INFORMATION FOR COMP (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18047893 ↗