Thoraflex™ Hybrid THP2628X100ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05037881026701), received between Aug 27, 2024 and Jan 8, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2026Off-Label Use; Device-Device Incompatibility

  THE SUPER-STIFF GUIDEWIRE WAS LIKELY COILED WITHIN THE DESCENDING AORTA. DURING ATTEMPTED WITHDRAWAL, THE WIRE APPEARED TO BEND, WHICH IN TURN CAUSED DEFORMATION OF THE APPLICATOR TIP AND PREVENTED WIRE RETRIEVAL. A 44-YEAR-OLD MALE PATIENT PRESENTED WITH AN ACUTE TYPE A AORTIC DISSECTION. THE DEVICE WAS OPENED AND PREPARED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). AN ANTEGRADE AMPLATZ SUPER-STIFF GUIDEWIRE WAS PLACED TO FACILITATE DELIVERY OF THE THORAFLEX HYBRID DEVICE. THE DEVICE WAS ADVANCED INTO POSITION, AND THE HANDLE WAS ACTUATED TO UNSHEATH THE STENT PORTION OF THE DEVICE. THE COLLAR HOLDER SUTURE WAS REMOVED AS PER STANDARD TECHNIQUE. UPON ATTEMPTED REMOVAL OF THE GUIDEWIRE, RESISTANCE WAS ENCOUNTERED, AND THE WIRE COULD NOT BE WITHDRAWN. THE SURGEON MADE MULTIPLE ATTEMPTS TO RETRIEVE THE WIRE; HOWEVER, IT WAS DETERMINED THAT THE WIRE HAD BECOME CAUGHT WITHIN THE DISTAL TIP OF THE APPLICATOR. INTRAOPERATIVE FINDINGS AND MANAGEMENT: THE SUPER-STIFF GUIDEWIRE WAS LIKELY COILED WITHIN THE DESCENDING AORTA. DURING ATTEMPTED WITHDRAWAL, THE WIRE APPEARED TO BEND, WHICH IN TURN CAUSED DEFORMATION OF THE APPLICATOR TIP AND PREVENTED WIRE RETRIEVAL. DUE TO THE INABILITY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24002710 ↗
• InjuryAug 27, 2024Adverse 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 FROM EXTEND-001 (NCT05639400) POST MARKET APPROVAL STUDY. THORAFLEX HYBRID PLEXUS WAS IMPLANTED IN A 52-YEAR-OLD (AT THE TIME OF CONSENT) MALE PATIENT, INDICATION FOR SURGERY: CHRONIC DISSECTION (DEBAKEY TYPE IIIB) AND POST-DISSECTION ANEURYSM. IMPLANT DATE (B)(6) 2024. EVENT DATE 31 JUL 24, 34 DAYS FROM PROCEDURE. NO SOURCE/MEDICAL NOTES HAVE BEEN UPLOADED INTO THE STUDY DATABASE FOR THIS EVENT SO FAR. THE SITE REPORTED THE EVENT OF PSEUDOANEURYSM (DESCRIPTION: INNOMINATE ARTERY PSEUDOANEURYSM) AS POSSIBLY RELATED TO THE THORAFLEX HYBRID DEVICE, RELATED TO THE PROCEDURE, AND NOT RELATED TO A PRE-EXISTING CONDITION. TREATMENT WAS REPORTED AS "STENT PLACEMENT-SUBCLAVIAN ARTERY". NOTE, NO DEVICE DEFICIENCY FORM HAS BEEN COMPLETED BY THE SITE TO DATE. THE OUTCOME HAS NOT YET BEEN PROVIDED IN THE STUDY DATABASE. THE SUBJECT REMAINS IN THE STUDY.

  Patient problems: Pseudoaneurysm

  MAUDE report 20074101 ↗