Cook brand Zenith Flex AAA Endovascular graft with the… recallZ-0518-05 · Cook, Inc. · initiated Dec 20, 2004
Terminated All recalls posted in February 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cook, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The firm has received complaints of difficulty in releasing the barbed suprarenal stent from the top cap that constrains it, which may result in misplacement of the graft.
FDA root cause category: Other
What the company is doing
Recall letter dated 12/20/04 was issued to each consignee via FedEx instructing them to cease using the products and to return them to the firm.
Recall details
- Recall number
- Z-0518-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 20, 2004
- Posted by the FDA
- Feb 3, 2005
- Recalling firm
- Cook, Inc.
- Product code
- MIH
- FDA submissions
- P020018
- Distribution
- Nationwide and Canada.
Product description
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 26mm, B=155mm, C=125mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-26-125.
Code information (models, lots, serial numbers)
All units distributed on or before 12/17/04.
Other devices under the same FDA submission
36 devices cleared under P020018 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Zenith G32551William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT5 deaths44 reports
- Zenith G32543William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT6 deaths18 reports
- Zenith G32554William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 deaths17 reports
- Zenith G32542William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 death15 reports
- Zenith G32539William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT14 reports
- Zenith G32537William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 death13 reports
- Zenith G32538William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT4 deaths13 reports
- Zenith G32544William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 deaths9 reports
- Zenith G32533William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 death8 reports
- Zenith G32532William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT7 reports
- Zenith G32550William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 deaths7 reports
- Zenith G32534William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 deaths6 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 30721).
- Z-0498-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System ( A= 22mm, B=112mm, C=82mm, D=11mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-22-8…
- Z-0499-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 24mm, B=112mm, C=82mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-24-82…
- Z-0500-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 26mm, B=112mm, C=82mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-26-82…
- Z-0501-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 28mm, B=112mm, C=82mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-28-82…
- Z-0502-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 30mm, B=112mm, C=82mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-30-82…
- Z-0503-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 32mm, B=112mm, C=82mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-32-82…
- Z-0504-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 22mm, B=126mm, C=96mm, D=11mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-22-96…
- Z-0505-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 24mm, B=126mm, C=96mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-24-96…
- Z-0506-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 26mm, B=126mm, C=96mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-26-96…
- Z-0507-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 28mm, B=126mm, C=96mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-28-96…
- Z-0508-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 30mm, B=126mm, C=96mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-30-96…
- Z-0509-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 32mm, B=126mm, C=96mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-32-96…
- Z-0510-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 22mm, B=141mm, C=111mm, D=11mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-22-1…
- Z-0511-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 24mm, B=141mm, C=111mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-24-1…
- Z-0512-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 26mm, B=141mm, C=111mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-26-1…
- Z-0513-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 28mm, B=141mm, C=111mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-28-1…
- Z-0514-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 30mm, B=141mm, C=111mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-30-1…
- Z-0515-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 32mm, B=141mm, C=111mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-32-1…
- Z-0516-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 22mm, B=155mm, C=125mm, D=11mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-22-1…
- Z-0517-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 24mm, B=155mm, C=125mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-24-1…
- Z-0519-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 28mm, B=155mm, C=125mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-28-1…
- Z-0520-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 30mm, B=155mm, C=125mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-30-1…
- Z-0521-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 32mm, B=155mm, C=125mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-32-1…
- Z-0522-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 26mm, B=170mm, C=140mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-26-1…
- Z-0523-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 28mm, B=170mm, C=140mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-28-1…
- Z-0524-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 30mm, B=170mm, C=140mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-30-1…
- Z-0525-05 · TerminatedCook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A=32mm, B=170mm, C=140mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-32-14…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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