Thoraflex™ Hybrid THP3034X100ERecalls & reported problems
Vascutek Ltd · Thoraflex Hybrid Plexus 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
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05037881173627), received between Jun 18, 2026 and Jun 18, 2026 — classified as 1 death.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJun 18, 2026Adverse Event Without Identified Device or Use Problem
PATIENT EXPIRED IN THE OPERATING ROOM AFTER A SUCCESSFUL THORAFLEX HYBRID DEPLOYMENT. SEVERE BLEEDING AT THE POSTERIOR COLLAR ANASTOMOSIS SITE DUE TO POOR TISSUE QUALITY (DISSECTION/ANEURYSMAL) AND CHALLENGING LOCATION TO REPAIR WITH SUTURE. OUTER STRIP OF FELT USED FOR INITIAL COLLAR ANASTOMOSIS FOLLOWED BY NUMEROUS PLEDGETS AFTER DISTAL RE-PERFUSION. THE CHEST INCISION WAS EXTENDED LATERALLY FOR BETTER AORTIC EXPOSURE. THE PATIENT DEVELOPED A SEVERE COAGULOPATHY AND MULTIPLE BLOOD TRANSFUSIONS. THE GORE REP WAS CALLED EMERGENTLY FOR DISTAL EXTENSIONS, AND TERUMO WAS INFORMED THE FOLLOWING MORNING THAT THE PATIENT EXPIRED ON THE OPERATING ROOM TABLE. ELOPED A SEVERE COAGULOPATHY AND MULTIPLE BLOOD TRANSFUSIONS. THE GORE REP WAS CALLED EMERGENTLY FOR DISTAL EXTENSIONS, AND TERUMO WAS INFORMED THE FOLLOWING MORNING THAT THE PATIENT EXPIRED ON THE OPERATING ROOM TABLE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25543717 ↗
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.
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