Thoraflex™ Hybrid THP2426X100ARecalls & reported problems
Vascutek Ltd · Thoraflex Hybrid Plexus 4 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05037881026695), received between Feb 11, 2025 and Feb 11, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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
- Deformation Due to Compressive Stress1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
EVENT DATE: (B)(6) 2024; IMPLANT DATE: (B)(6) 2024. E-MAIL NOTIFICATION RECEIVED FROM CORE LABORATORY (EXTEND STUDY (B)(6)) ON 16TH JANUARY 2025 REPORTING THE FOLLOWING: 62.5% - DEVICE KINKING - THORAFLEX HYBRID. CT SCANS (PRE-PROCEDURE (B)(6) 2024 AND POST-PROCEDURE (B)(6) 2024) ARE AVAILABLE IN THE MEDIDATA DATABASE AND CAN BE SHARED UPON REQUEST. THERE WERE NO ISSUES REPORTED BY THE SITE ON THE POST-PROCEDURE ASSESSMENT FORM IN THE STUDY DATABASE. THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00012 TO PROVIDE EVENT CLOSURE INFORMATION FOR TGA0140.
Patient problems: Insufficient Information
MAUDE report 21352954 ↗
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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