Thoraflex™ Hybrid THP3034X150ARecalls & 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
- 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 05037881026831), received between May 28, 2024 and Mar 25, 2025 — 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 Problem2
- Insufficient Device Problem Information1
Patient problems
- Kidney injury1
- Paraplegia1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
ON POST-OPERATIVE DAY 1, SITE REPORTED AN ADVERSE EVENT OF ACUTE KIDNEY INJURY' - WITH FURTHER DETAILS STATING NEPHROLOGY CONSULTED. THE EVENT WAS CONSIDERED ]UNRESOLVED, STILL TREATING' AT TIME OF REPORT. THE PATIENT CONTINUED IN THE STUDY. CONCOMITANT MEDICATIONS TAKEN AT THE TIME OF THE EVENT INCLUDE ASPIRIN, CLONIDINE, METOPROLOL TARTRATE, NIFEDIPINE, HEPARIN AND PROTAMINE.
Patient problems: Kidney injury
MAUDE report 21686748 ↗InjuryMay 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
EVENT REPORTED TO TAG COMPLAINTS ON 01 MAY 24, EVENT OCCURRED ON 26 APR 24. IMPLANT DATE ON (B)(6) 2024. OPERATION WAS COMPLETED SUCCESSFULLY AND PATIENT WAS TAKEN TO RECOVERY. AFTER 20 - 40 MINUTES THE PATIENTS MAP (MEAN ARTERIAL PRESSURE) DROPPED TO 67MMHG. THE NEXT MORNING( ON (B)(6) 2024) IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PARAPALEGIC EVENT AND CAN NO LONGER MOVE HIS LOWER EXTREMITIES. RELEVANT MEDICAL CONDITIONS: ACUTE TYPE B DISSECTION THAT ORIGINATED IN ZONE 2 IN THE ARCH. PATIENT PRESENTED WITH PAIN AND A PLUERAL EFFUSION PATIENT OUTCOME: CURRENTLY NO CHANGE. STILL PARALYSED FROM THE WAIST DOWN AND INTUBATED.
Patient problems: Paraplegia
MAUDE report 19403238 ↗
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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