Thoraflex™ Hybrid THP3036X150BRecalls & reported problems
Vascutek Ltd · Thoraflex Hybrid Plexus · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05037881031873), received between Sep 24, 2025 and Sep 24, 2025 — classified as 1 injury.
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
- No Clinical Signs, Symptoms or Conditions1
- Thrombosis/Thrombus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
EVENT WAS REPORTED BY CLINICAL STUDY EXTEND - (B)(6), EVENT WAS FOR RIGHT COMMON FEMORAL ARTERY THROMBOSIS. PATIENT'S THORAFLEX HYBRID IMPLANT TOOK PLACE ON (B)(6) 2025. ON INDEX POD 120 ((B)(6) 2025), THE DAY OF THE EXTENSION PROCEDURE, THE PATIENT EXPERIENCED AN EVENT OF RIGHT COMMON FEMORAL ARTERY THROMBOSIS, DESCRIBED BY THE SITE AS "CONVERSION TO OPEN FOR REPAIR OF THE RIGHT SCARPA ON THROMBOSIS OF THE RIGHT COMMON FEMORAL ARTERY". SEVERITY OF THE EVENT WAS REPORTED AS MILD. RELAYPRO EXTENSION WAS IMPLANTED ON (B)(6) 2025. THE SITE HAVE INDICATED THAT THE EVENT IS POSSIBLY RELATED TO DEVICE (UNDETERMINED AS TO WHETHER THIS IS THE THORAFLEX HYBRID OR RELAYPRO), RELATED TO THE RELAYPRO EXTENSION PROCEDURE, AND NOT ASSOCIATED WITH A DEVICE DEFICIENCY. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00082 TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0321.
Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus
MAUDE report 23130371 ↗
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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