Severity
Critical
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 that is suitable for access with the required introduction systems, " Nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic lesion: " with a length of
Reported: August 16, 2017 Initiated: March 22, 2017 #Z-2099-2017 4916 units
Cook Medical Incorporated issued this FDA Devices recall on August 16, 2017. Classified as Critical severity (Class I). Approximately 4916 units are affected. The recall was issued because: There have been five reports of graft thrombosis/occlusion during global commercial use, each following treatment for …. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-2099-2017) was formally reported on August 16, 2017, with the manufacturer initiating the action on March 22, 2017. It is classified under Critical severity (Class I), with a current status of Terminated. Cook Medical Incorporated is listed as the recalling firm, operating out of Bloomington, IN. Federal records indicate 4916 units are affected.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Nationwide Distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 9 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
4916
Related Recalls
6
6 from same agency
Recall Progress (industry avg ~60%) 60.0%
Product Description
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 that is suitable for access with the required introduction systems, " Nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic lesion: " with a length of at least 20 mm, and " with a diameter measured outer wall to outer wall of no greater than 42 mm and no less than 15 mm.
Reason for Recall
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.
Details
- Recalling Firm
- Cook Medical Incorporated
- Units Affected
- 4916
- Distribution
- Nationwide Distribution.
- Location
- Bloomington, IN
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2099-2017 |
| Date reported | August 16, 2017 |
| Date initiated | March 22, 2017 |
| Recalling firm | Cook Medical Incorporated |
| Units affected | 4916 |
| Distribution | Nationwide Distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
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 that is suitable for access with the required introduction systems, " Nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic lesion: " with a length of at least 20 mm, and " with a diameter measured outer wall to outer wall of no greater than 42 mm and no less than 15 mm.. Recalled by Cook Medical Incorporated. Units affected: 4916.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 16, 2017. Severity: Critical. Recall number: Z-2099-2017.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2099-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Recall Context
Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as critical severity, meaning the product carries a reasonable probability of serious adverse health consequences or death. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).