Zenith Alpha G35519Recalls & reported problems

William Cook Europe ApS · Zenith Alpha, Thoracic Endovascular Graft, Distal Extension · Class 3 · Implant

All models of Zenith Alpha (67)

Data updated Oct 16, 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 10827002355191), received between Jan 16, 2025 and Jan 16, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Detachment of Device or Device Component1

Patient problems

Hemorrhage/Blood Loss/Bleeding1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJan 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DEPLOYED THE DEVICE WITH NO PROBLEM. WHEN REMOVING THE DELIVERY SYSTEM FORM THE SHEATH, THE PATIENT STARTED BLEEDING. IT STOPPED WHEN THE SHEATH VALVE WAS TURNED TO A CLOSED POSITION, BUT ABNORMAL AMOUNT OF BLEEDING THROUGH VALVE WHEN OPEN. PATIENT OUTCOME: THE BLOOD LOSS WAS APPROXIMAL 50ML. THE PATIENT DID NOT REQUIRE ANY TREATMENT OR BLOOD TRANSFUSION FOR THE BLOOD LOSS.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21166068 ↗

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, Classified
Zenith 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 · Terminated
Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with isolated lesions of the descend

Device details

UDI-DI	`10827002355191`
Brand	Zenith Alpha
Model	G35519
Catalog no.	ZTA-DE-34-112-W
Company	William Cook Europe ApS
Product code	MIH · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Class	Class 3
FDA submission	P140016
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Apr 30, 2026

Device type (GMDN): Descending thoracic aorta endovascular stent-graft

A non-bioabsorbable tubular device intended to be implanted within the descending thoracic aorta to repair the vessel [includes repair of thoracic aortic aneurysm (TAA), traumatic transsections/dissections, fistulae, penetrating ulcers]; it is not intended for implantation within the aortic arch. It is typically made of a metal alloy [e.g., nickel-titanium alloy (Nitinol)] that forms an outer mesh structure with an inner synthetic polymer tube (endovascular graft) and is typically designed as a single continuous tube which may be used in singular and/or modular configurations. It is intended for percutaneous introduction; disposable delivery device (e.g., balloon catheter) may be included.

Other SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices

Endurant® IIs ESBF2814C103E
Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
2 recalls34 deaths254 reports
Endurant® IIs ESBF3214C103E
Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
2 recalls19 deaths173 reports
Endurant® IIs ESBF3614C103E
Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
1 recall37 deaths214 reports
Endurant® IIs ESBF2514C103E
Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
2 recalls18 deaths136 reports
Endurant® IIs ESBF2314C103E
Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
2 recalls9 deaths60 reports
RelayPro Thoracic Stent-Graft System 28-N4-34-154-34U
Bolton Medical Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
3 recalls7 reports
Vela Proximal Endograft System A34-34/C100-O20 V
Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
3 deaths152 reports
Endurant® II ETCF2828C49E
Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
2 recalls7 deaths44 reports

All SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices →

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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page