Thoraflex™ Hybrid THP2628X100BRecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05037881031736), received between Oct 21, 2025 and Jul 15, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Twisted/Bent” (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
- Material Twisted/Bent1
Patient problems
- Aortic dissection1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem
AS REPORTED FROM THE THOR STUDY (NCT03414866). ON POST OPERATIVE DAY 1 (ON (B)(6) 2021), PATIENT 029 HAD AN ADVERSE EVENT OF DSINE (DISTAL STENT GRAFT INDUCED NEW ENTRY) (ON CT SCAN FROM ON (B)(6) 2021 WAS A DSINE DETECTABLE). TREATMENT OF THIS ADVERSE EVENT INCLUDED REINTERVENTION, TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR) -IMPLANTATION ON (B)(6) 2021. THE EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2021 AND THE PATIENT CONTINUED IN THE STUDY. CONCOMITANT MEDICATIONS INCLUDED: ENOXAPARIN (CLEXANE S.C.), ACETYLSALICYLIC ACID (ASS). THE INVESTIGATOR CONSIDERED THE EVENT OF DSINE AS MODERATE SEVERITY AND RELATED TO THE THORAFLEX HYBRID PLEXUS DEVICE.
Patient problems: Aortic dissection
MAUDE report 25823704 ↗MalfunctionOct 21, 2025Material Twisted/Bent; Material Twisted/Bent
EVENT REPORTED FORM EXTEND STUDY (NCT05639400). SUBJECT UNDERWENT AN EMERGENT (WITHIN 24 HOURS) OPEN SURGICAL REPAIR OF THE AORTA WITH A THORAFLEX PLEXUS HYBRID DEVICE ON (B)(6) 2025. INDICATION FOR REPAIR WAS TO TREAT A HYPERACUTE (<24HRS) DEBAKEY TYPE I AORTIC DISSECTION. DEVICE KINKING WAS NOTED A FEW DAYS LATER ((B)(6) 2025) VIA COMPUTED TOMOGRAPHY ANGIOGRAPHY (CT ANGIOGRAM) PREFORMED. SURGICAL INTERVENTION WAS PERFORMED - A FET BALLOON ANGIOPLASTY AND THORACIC ENDOVASCUAR AORTIC REPAIR PROCEDURE WAS PERFORMED ON (B)(6) 2025. REPORTED AS RELATED TO DEVICE FAILURE / DEFICIENCY, WITH SURGICAL INTERVENTION. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00085 TO PROVIDE EVENT CLOSURE INFORMATION FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 23346320 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page