Thoraflex™ Hybrid THP3038X100BRecalls & 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
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05037881031781), received between Apr 7, 2026 and Apr 7, 2026 — classified as 1 death.
The most frequently reported specific device problem is “Microbial Contamination of Device” (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
- Microbial Contamination of Device1
Patient problems
- Bacterial Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathApr 7, 2026Microbial Contamination of Device
EVENT OF INFECTION REPORTED FROM (B)(6). DEATH OF THE PATIENT IN RESUSCITATION. PATIENT OPERATED ON (B)(6) 2025 FOR A REPLACEMENT OF THE AORTIC ARCH WITH REIMPLANTATION OF THE SUPRA-AORTIC TRUNKS AND PLACEMENT OF A DESCENDING THORACIC AORTIC PROSTHESIS (THORAFLEX), ON AN ANEURYSM OF THE AORTIC ARCH. NEW HOSPITALIZATION ON 25/10 FOR FEVER AND PERIPROSTHETIC COLLECTION. SURGICAL DRAINAGE OF A PURULENT PERICARDIAL COLLECTION THAT CAME BACK POSITIVE FOR CUTI BACTERIUM ACNES WITH IRRIGATION, WASHING, THEN ACTIVE DRAINAGE UNTIL 17/11 ONCE THE BACTERIOLOGICAL SAMPLES ARE NEGATIVE. ON (B)(6) 2025: PET-CT PERFORMED OBJECTIFYING THE PRESENCE OF A THORACIC HYPERMETABOLIC INFILTRATION COMING INTO CONTACT WITH THE ASCENDING THORACIC AORTIC PROSTHESIS, THE SITE OF HETEROGENEOUS FIXATION: SUSPICION OF A PROGRESSIVE INFECTIOUS PROCESS. HOSPITALIZATION IN CARDIAC SURGERY FOR NEW SURGICAL TRIMMING AND DRAINAGE BY STERNAL VAC (UNDERSTOOD TO BE VACUM ASSISTED CLOSURE SYSTEM) AND INFECTIOUS FOLLOW-UP SCINTIGRAPHY WITH LABELED LEUKOCYTES (B)(6) 2026, REVEALING AN INFECTION OF THE AORTIC PROSTHESIS, WITHOUT ANY OTHER HYPER FIXATION FOCUS. ON (B)(6) 2026: COMPLETE SURGICAL REVISION FOR REMOVAL - REINSTALL
Patient problems: Bacterial Infection
MAUDE report 24797689 ↗
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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