Zenith Alpha G35365Recalls & reported problems
William Cook Europe ApS · Zenith Alpha, Thoracic Endovascular Graft, Proximal Component · Class 3 · Implant
Data updated Oct 13, 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 10827002353654), received between Nov 10, 2016 and Nov 10, 2016 — classified as 1 death.
The most frequently reported specific device problem is “Difficult To Position” (1 report).
2 other recalls cover devices cleared under the same FDA submission (P140016); they may or may not involve this specific model.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Difficult To Position1
Patient problems
- Death1
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathNov 10, 2016Difficult To Position; Difficult To Position
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "THE ZTA-PT-46-42-179-W WAS DEPLOYED WITHOUT INCIDENT OVER THE LUNDERQUIST DOUBLE CURVE. THE SECOND DEVICE ZTA-P-121-W WAS ADVANCED INTO THE PRIMARY DEVICE AND IT WOULD NOT TRACK, IT WAS GETTING CAUGHT IN THE PRIMARY DEVICE. IT THEN JUMPED AND THE NOSE CONE OF THE DELIVERY SYSTEM INADVERTENTLY PUSHED THE LUNDERQUIST WIRE TO DISSECT THE INNOMINATE ARTERY." PATIENT OUTCOME: "[PT] IS DECEASED."
Patient problems: Death; Vascular Dissection
MAUDE report 6092043 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P140016. One submission often covers many models, so check the product and lot details in each record.
- Z-0043-2026 · Sep 18, 2025 · Open, ClassifiedZenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W ZTA2-P-40-217-W ZTA2-P-42-121 ZTA2-P-42-121-W
- Z-2099-2017 · Mar 22, 2017 · TerminatedZenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with isolated lesions of the descend
Other SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices
- Endurant® IIs ESBF2814C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls34 deaths254 reports
- Endurant® IIs ESBF3214C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls19 deaths173 reports
- Endurant® IIs ESBF3614C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall37 deaths214 reports
- Endurant® IIs ESBF2514C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls18 deaths136 reports
- Endurant® IIs ESBF2314C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls9 deaths60 reports
- RelayPro Thoracic Stent-Graft System 28-N4-34-154-34UBolton Medical Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment3 recalls7 reports
- Vela Proximal Endograft System A34-34/C100-O20 VEndologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment3 deaths152 reports
- Endurant® II ETCF2828C49EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls7 deaths44 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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