Thoraflex™ Hybrid THP3032X150BRecalls & 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 05037881031859), received between Sep 10, 2025 and Sep 10, 2025 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Aortic dissection1
- 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 10, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
EVENT OF ARTERY DISSECTION REPORTED FROM EXTEND STUDY ((B)(4)) OF PATIENT (B)(6). ON POST OPERATIVE DAY 1 (B)(6) 2025) HAD A SUPERIOR MESENTERIC ARTERY DISSECTION WITH FLOATING THROMBUS. TREATMENT OF THE EVENT WAS BY HEPARIN. THE EVENT WAS CONSIDERED UNRESOLVED NOT TREATING AT THE TIME OF THIS REPORT. THE INVESTIGATOR CONSIDERED THE EVENT OF ARTERY DISSECTION AS SERIOUS WITH MILD SEVERITY, UNANTICIPATED, RELATED TO A PRE-EXISTING CONDITION, NOT RELATED TO THE PROCEDURE OR THE DEVICE WITH NO DEVICE DEFICIENCY. THE PATIENT CONTINUED IN THE STUDY.
Patient problems: Aortic dissection; Thrombosis/Thrombus
MAUDE report 23016489 ↗
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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