What is being recalled?

Cook Medical recalls 695 Zenith Alpha 2 Thoracic Endovascular Grafts due to PTFE coating scrapings that could be released during deployment and cause intravascular embolization.

How many devices are affected?

A total of 695 devices are affected by this recall.

Who is affected by the recall?

Devices with the Zenith Alpha 2 labeling distributed to domestic hospitals and international distributors, including the listed countries.

What should I do if I own one of these devices?

Stop using the device immediately. Follow the recall instructions provided by Cook Medical and consult your healthcare provider for guidance.

How can I tell if my device is in the recall?

Check the device catalog prefix ZTA2 and compare the reference part numbers against the recall list. Also review UDI and lot numbers associated with your device.

Is there an immediate danger from using an affected device?

Yes, deployment could release PTFE scrapings and cause intravascular embolization, which is a serious complication.

The remedy is to stop using the device and follow recall instructions. Contact Cook Medical or your healthcare provider for further steps and potential refunds or replacements.

Will I receive a refund or replacement?

The recall notice directs providers to follow the manufacturer’s instructions. Specific refund or replacement details are communicated through the recall notice and physician channels.

How long will the recall process take?

The recall notice does not specify a timeline for refunds or replacements. Hospitals coordinate with Cook Medical per the recall notice.

Where can I get more information?

Refer to the FDA enforcement recall page with the recall number Z-0043-2026 and Cook Medical communications for guidance.

What should I do if the hospital is slow to respond?

Document all communications, escalate through hospital risk management, and contact FDA MedWatch if needed.

If I’ve already implanted an affected device, what should I do?

Consult the operating surgeon and hospital risk management to determine next steps, including monitoring and potential removal or replacement as advised.

HIGHSeptember 18, 2025

Cook Medical Zenith Alpha 2 Thoracic Graft Recall Affects 695 Devices in 2025

Cook Medical recalled 695 Zenith Alpha 2 Thoracic Endovascular Grafts distributed to hospitals domestically and internationally. A defect could cause PTFE coating scrapings to be released during deployment, risking intravascular embolization. Healthcare providers and patients should stop using the device and follow the manufacturer’s recall instructions.

Quick Facts at a Glance

Recall Date: September 18, 2025
Hazard Level: HIGH
Brand: Cook Medical
Category: Health & Personal Care
Sold At: Unknown
Geographic Scope: Nationwide (50 states)
At-Risk Groups: GENERAL

Hazard Information

Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cook Medical Incorporated or your healthcare provider for instructions. Notification method: Letter

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About This Product

The Zenith Alpha 2 line comprises thoracic endovascular grafts used to treat thoracic aortic pathologies. They are implanted by vascular surgeons to reinforce the aorta. The devices are part of a broader class of stent grafts often used in endovascular repair.

Why This Is Dangerous

PTFE coating scrapings may be present on the grafts. During deployment, scrapings could detach and travel within the bloodstream, potentially causing embolization.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Hospitals and patients may face procedure delays or revision surgeries. The recall emphasizes careful device verification and adherence to recall instructions to prevent serious complications.

Practical Guidance

How to identify if yours is affected

Verify catalog prefix ZTA2.
Cross-check reference part numbers listed in the recall with your device lid and packaging.
Inspect for corresponding UDI-DI and lot numbers from the recall list.

Where to find product info

Device labels include UDI-DI. Recall notices provide box UDI-DI, product UDI-DI, and lot numbers.

What timeline to expect

Timeline for refunds or replacements is not specified in the recall notice.

If the manufacturer is unresponsive

Escalate with hospital procurement and risk management.
Request formal recall documentation and a written plan from the supplier.
File a report with FDA MedWatch if the supplier is unresponsive.

How to prevent similar issues

Institute strict UDI and lot-number verification for all thoracic endovascular grafts.
Request up-to-date recall status from suppliers and distributors.
Educate surgical teams on recognizing recall items during inventory checks.

Documentation advice

Keep all recall notices, packaging, UDI codes, lot numbers, and correspondence with the manufacturer for records.

Product Details

Catalog Prefix ZTA2; Reference Part Numbers include 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, ZTA2-P-42-173, ZTA2-P-42-173-W, ZTA2-P-42-225, ZTA2-P-42-225-W, ZTA2-P-44-125, ZTA2-P-44-125-W, ZTA2-P-44-179, ZTA2-P-44-179-W, ZTA2-P-44-233, ZTA2-P-44-233-W, ZTA2-P-46-125, ZTA2-P-46-125-W, ZTA2-P-46-179, ZTA2-P-46-179-W, ZTA2-P-46-233, ZTA2-P-46-233-W, ZTA2-PT-40-36-167, ZTA2-PT-40-36-167-W, ZTA2-PT-40-36-217, ZTA2-PT-40-36-217-W, ZTA2-PT-42-38-173, ZTA2-PT-42-38-173-W, ZTA2-PT-42-38-225, ZTA2-PT-42-38-225-W, ZTA2-PT-44-40-179, ZTA2-PT-44-40--

Reported Incidents

No injuries or incidents have been reported.

Key Facts

695 units recalled
Domestic distribution to AL, AR, AZ, CA, CT, DC, DE, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NJ,
NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV
International distribution to Switzerland, Germany, Italy, Poland, Sweden
Recall date: 2025-09-18; Report date: 2025-10-22
Hazard: PTFE coating scrapings could cause intravascular embolization

View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeThoracic Endovascular Graft

Product Details

May 7, 2026

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