Thoraflex™ Hybrid THA2830X150ARecalls & reported problems
Vascutek Ltd · Thoraflex Hybrid Ante-Flo Hybrid Stent Device · Class 3 · Implant
All models of Thoraflex Hybrid (33)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05037881027029), received between Mar 4, 2025 and Mar 4, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Migration1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2025Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration
EVENT NAME: MIGRATION OF 20MM IN PROXIMAL DIRECTION (NEW). NOTE, AS PER THE STUDY DATABASE, THIS SUBJECT UNDERWENT AN EXTENSION PROCEDURE ON (B)(6) 2025. DEVICE INFORMATION IS INCOMPLETE ON THE FORM BUT IS AS FOLLOWS: (1) RELAYPRO NBS, 28-M4-36-145-36U, (B)(6) (2) 28-M4-44-155-44U, (B)(6) CT SCANS (DATED (B)(6) 2024) AND AN X-RAY ANGIOGRAPHY (DATED (B)(6) 2025). THERE WERE NO ISSUES REPORTED BY THE SITE FOLLOWING ANY OF THE IMPLANTS OR ON THE POST-PROCEDURE ASSESSMENTS FORMS IN THE STUDY DATABASE. THE SITE HAVE NOT REPORTED ANY DEVICE DEFICIENCIES. SITE HAVE BEEN ADVISED OF THE CORE LABORATORY OBSERVATION WITH A REQUEST TO CONSIDER REPORTING AN ADVERSE EVENT AND/OR DEVICE DEFICIENCY. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00014 TO PROVIDE EVENT CLOSURE INFORMATION FOR (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 21512459 ↗
Other Hybrid stent graft, thoracic aortic lesion treatment devices
- Thoraflex™ Hybrid THP3032X100AVascutek Ltd · Hybrid stent graft, thoracic aortic lesion treatment3 deaths8 reports
- Thoraflex™ Hybrid THP3036X100AVascutek Ltd · Hybrid stent graft, thoracic aortic lesion treatment7 reports
- Thoraflex™ Hybrid THP3032X150AVascutek Ltd · Hybrid stent graft, thoracic aortic lesion treatment4 reports
- Thoraflex™ Hybrid THA3036X150AVascutek Ltd · Hybrid stent graft, thoracic aortic lesion treatment4 reports
- Thoraflex™ Hybrid THP2830X100AVascutek Ltd · Hybrid stent graft, thoracic aortic lesion treatment4 reports
- Thoraflex™ Hybrid THP3036X150AVascutek Ltd · Hybrid stent graft, thoracic aortic lesion treatment1 death3 reports
- Thoraflex™ Hybrid THA3032X150AVascutek Ltd · Hybrid stent graft, thoracic aortic lesion treatment2 deaths3 reports
- Thoraflex™ Hybrid THA2830X100AVascutek Ltd · Hybrid stent graft, thoracic aortic lesion treatment1 death3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page