Device recall: Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the…

Class I FDA enforcement event 77099. Recall start date: 22 Mar 2017. Status in the FDA record: Terminated. Termination date: 14 Feb 2019.

Reason for recall, in the words of FDA

There have been five reports of graft thrombosis/occlusion during global commercial use, each following treatment for BTAI. One case resulted in patient death, and three cases resulted in reintervention.

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Cook Medical Incorporated started this device recall on 22 Mar 2017. The firm address in the FDA record is in Bloomington, IN. FDA put the recall in Class I. FDA event 77099 has 1 product record. The first FDA enforcement report date is 16 Aug 2017. The record gives the status Terminated, with the termination date 14 Feb 2019.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide Distribution.

Recalling firm

Cook Medical Incorporated, Bloomington, IN.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 77099: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2099-2017	Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular repair including: " Iliac/femoral anatomy…	4916	Class I	Terminated	16 Aug 2017

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2017: 1,091
Share of these events in Class I: 3%
Product records in this event: 1Median of the firm: 2
Events of the firm on the register: 8

Other events of the firm

Other FDA enforcement events of Cook Medical Incorporated
Initiated	Product (first record)	Type	Class	Records
18 Sep 2025	Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZT	Device	Class I	1
1 Apr 2024	EchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012	Device	Class II	2
14 Feb 2022	Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65	Device	Class III	2
25 Feb 2019	Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIP Product Usage: The G	Device	Class III	6
25 Sep 2018	Zilver 518 Biliary Stent 4mm x 20mm, Catalog Number: ZIB5-125-4.0-20 Product Usage: The Zilver 518 and 635 Biliary Stent	Device	Class II	39
22 Dec 2015	Zilver 518RX Vascular Stent with Rapid Exchange Delivery System	Device	Class II	1
26 Sep 2014	Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-part introducer needle that con	Device	Class II	1

Cook Medical Incorporated: all 8 events

Official channels

FDA enforcement report Z-2099-2017The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 77099. https://recallregister.com/fda/i/77099/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide Distribution.
What quantity of product is in FDA event 77099?: The FDA record gives this quantity: 4916
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2017 have the same class?: 3% of the 1,091 device events that started in 2017 are in Class I.