Thoraflex™ Hybrid THP3040X100BRecalls & 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
- 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 05037881031798), received between Aug 21, 2025 and Aug 21, 2025 — classified as 1 death.
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
Patient problems
- Sepsis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathAug 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
INFECTION EVENT REPORTED FORM THE EXTEND STUDY (NCT05639400). SUBJECT CAUCASIAN MALE( WHO WAS 79 AT THE TIME OF CONSENT TAKEN ON (B)(6) 2025) UNDERWENT AN ELECTIVE OPEN SURGICAL REPAIR OF THE AORTA WITH A THORAFLEX HYBRID PLEXUS DEVICE ON (B)(6) 2025, FOR FUSIFORM AORTIC ANEURYSM. ON POST-OPERATIVE DAY 8 (B)(6) 2025), SUBJECT (B)(6) EXPERIENCED AN SAE( SERIOUS ADVERSE EVENT) OF INFECTION, FURTHER DETAILS STATING "BLOOD STREAM INFECTION WITH VANCOMYCIN RESISTANT ENTEROCOCCI (FAECUM), VRE (VANCOMYCIN-RESISTANT ENTEROCOCCUS).INCLUDING INFECTION OF THE AORTIC PROSTHESIS. POSITIVE BLOOD CULTURE FOUND IN INTRA-SURGICAL SAMPLE TAKEN ON (B)(6) 2025. EVENT IS ANTICIPATED AND SEVERE IN NATURE. EVENT WAS CONSIDERED POSSIBLY RELATED TO DEVICE, NOT RELATED TO DEVICE FAILURE/DEFICIENCY AND NOT RELATED TO PRE-EXISTING CONDITIONS. PATIENT PASSED AWAY ON (B)(6) 2025. SITE DETAILED REASON FOR DEATH AS "PALLIATIVE TREATMENT IN TERMS OF BEST SUPPORTIVE CARE AND ACCORDING TO PATIENT'S WILL".
Patient problems: Sepsis
MAUDE report 22858270 ↗
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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