Thoraflex™ Hybrid THA3240X150ARecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05037881027081), received between Apr 28, 2025 and Sep 25, 2026 — classified as 2 injuries.
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
- Clinical Endoleak1
- Paresis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Insufficient Device Problem Information
Event reported from clinical study Extend - NCT05639400.Type 1C Endoleak, was noted intraoperatively from right renal bridging stent on (b)(6) 2026 for patient (b)(6).Treatment of the event included a VBX stent placement on (b)(6) 2026. The event was considered resolved with treatment and sequalae on (b)(6) 2026. The patient continued in the study.The investigator considered the event of Type 1C Endoleak as serious with moderate severity and related to the device.The site provided an update on 28 Aug 26 stating that this event is related to the Thoraflex Hybrid procedure and related to the Thoraflex Hybrid device.
Patient problems: Clinical Endoleak
MAUDE report 50895652 ↗InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FOLLOWING PROCEDURE PERFORMED ON (B)(6) 2025, SUBJECT (B)(6) EXPERIENCED AN EVENT OF LEFT LOWER EXTREMITY WEAKNESS ON (B)(6) 2025. TREATMENT OF THE EVENT INCLUDED A LUMBAR DRAIN WHICH WAS PLACED ON (B)(6) 2025. THE EVENT IS ONGOING AT TIME OF REPORTING. THE SUBJECT CONTINUES IN THE STUDY. CONCOMITANT MEDICATIONS INCLUDE AMIODARONE, AMLODIPINE, FUROSEMIDE, ESMOLOL, HEPARIN, AMINOCAPROIC ACID, NICARPIDINE, VASOPRESSIN, HUMAN ALBUMIN, ASPIRIN AND METROPOLOL. THERE WAS NO DEVICE FAILURE/DEFICIENCY REPORTED.
Patient problems: Paresis
MAUDE report 21917302 ↗
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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