Thoraflex™ Hybrid THP2830X150BRecalls & 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 05037881031842), received between Jul 22, 2025 and Jul 22, 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
- Insufficient Device Problem Information1
Patient problems
- Paresis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
EVENT REPORTED FORM EXTEND CLINICAL STUDY (B)(6) SUBJECT (B)(6), A 64-YEAR-OLD (AT THE TIME OF CONSENT TO THE TRIAL) CAUCASIAN MALE WITH HYPERACUTE (<24HRS) DEBAKEY TYPE I AORTIC DISSECTION. THE SUBJECT UNDERWENT AN EMERGENT OPEN SURGICAL REPLACEMENT OF THE AORTA WITH A THORAFLEX HYBRID PLEXUS DEVICE ON (B)(6) 2025. THEN EXPERIENCED A SERIOUS ADVERSE EVENT (SAE) OF SPINAL CORD ISCHAEMIA (PROBABLE)' WITH FURTHER DETAILS STATING "PARAPLEGY, RIGHT UPPER LIMB MONOPLEGIA AND LEFT UPPER LIMB MONOPARESIS". SURGICAL INTERVENTION - A LUMBAR PUNCTURE WAS PERFORMED. THE INVESTIGATOR CONSIDERS THE SAE AS UNANTICIPATED, RELATED TO PROCEDURE, RELATED TO DEVICE, NOT RELATED TO DEVICE DEFICIENCY AND NOT RELATED TO A PRE-EXISTING CONDITION. . THE EVENT IS REPORTABLE AFTER MEDICAL MONITOR ASSESSMENT, WITH THE OUTCOME OF ASSESSMENT BEING] POSSIBLY RELATED TO DEVICE'.
Patient problems: Paresis
MAUDE report 22563115 ↗
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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