Thoraflex™ Hybrid THA2628X150ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05037881027012), received between Apr 16, 2024 and Oct 8, 2024 — classified as 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 8, 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 DATE: 09 SEP 24 IMPLANT DATE: (B)(6) 2024. EVENT AS REPORTED BY EXTEND-001 CLINICAL STUDY: THE PATIENT HAD A STROKE, BUT THE PATIENT WAS ABLE TO MOVE ALL EXTREMITIES BUT SUFFERED FROM DYSPHASIA SO A CT STROKE WAS ORDERED. IT DEMONSTRATED A NEW POSTERIOR INFARCT) AS POSSIBLY RELATED TO THE THORAFLEX HYBRID DEVICE, RELATED TO THE PROCEDURE (LIKELY DUE TO WIRE ADVANCEMENT PRIOR TO THORAFLEX DEPLOYMENT), AND RELATED TO A PRE-EXISTING CONDITION. THE SUBJECT'S CURRENT MRS (UNDERSTOOD TO BE MODIFIED RANKIN SCALE) SCORE AT 30-90 DAYS POST ONSET OF STROKE WAS GRADED AS A 3 (MODERATE DISABILITY; REQUIRING SOME HELP, BUT ABLE TO WALK WITHOUT ASSISTANCE). NO ACTION WAS TAKEN TO TREAT THE ADVERSE EVENT. THE OUTCOME HAS BEEN REPORTED AS "ONGOING" WITH THE CURRENT STATUS REPORTED AS "UNRESOLVED STILL TREATING". THE SUBJECT REMAINS IN THE STUDY. THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP 1 FOR MANUFACTURING REPORT # 9612515-2024-00072 TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0055

  Patient problems: Stroke/CVA

  MAUDE report 20395566 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  NON-SERIOUS ADVERSE EVENT OF ENDOLEAK REPORTED FROM (B)(6) POST MARKET STUDY SITE (B)(4) PATIENT NUMBER (B)(6). THE EVENT OF ENDOLEAK (31 DAYS POST OP) WAS REPORTED IN THE STUDY DATABASE BY THE STUDY HOSPITAL/SITE WITH NO CAUSALITY ASSESSMENTS COMPLETED. THE EVENT DESCRIPTION WAS AS FOLLOWS: DILATATION OF THE STENTED AORTIC ARCH WITH A MAXIMUM DIAMETER OF 3.9 CM, SLIGHTLY DECREASED, PREVIOUSLY 4.2 CM. THE HOSPITAL/SITE HAVE NOT YET COMPLETED THE QUESTIONS ON CAUSALITY IN THE STUDY DATABASE, NOR THE QUESTION ON ANY ACTION TAKEN TO TREAT THE ADVERSE EVENT. THE SITE HAVE HOWEVER REPORTED THIS AS A NON-SERIOUS ADVERSE EVENT. THE SITE HAS NOT COMPLETED A DEVICE DEFICIENCY FORM IN THE STUDY DATABASE. FURTHER INFORMATION RECEIVED FROM THE SITE ON (B)(6) 2024. SAC REGRESSION WAS OBSERVED POST OPERATIVELY, NOT ASSOCIATED WITH MIGRATION, INTEGRITY FAILURE OR MODULE SEPARATION. INITIALLY REPORTED AS ENDOLEAK, THEN UPDATED TO NO ENDOLEAK, PERSISTENT FLOW IN THE FALSE LUMEN. FOLLOW UP#3 SEE NARRATIVE IN SECTION H11.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19114642 ↗