# P020018: Zenith Aaa Endovascular Graft and H&L-B One-Shot Introductino System

- Pathway: PMA
- Applicant: Cook, Inc.
- Decided: May 23, 2003 after 364 days
- Product code: MIH (System, Endovascular Graft, Aortic Aneurysm Treatment)
- Device class: 3
- Recalls of this device: 111 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Apr 15, 2011 · Not classified · Z-3154-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3137-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3143-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3144-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3153-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3145-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3147-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3135-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3134-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3152-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3133-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3158-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3132-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3139-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3157-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3156-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3142-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3155-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3140-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3148-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3146-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3151-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3150-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3131-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3130-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3138-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3141-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3136-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Apr 15, 2011 · Not classified · Z-3149-2011: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
- Dec 20, 2004 · Not classified · Z-0514-05: 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.
- Dec 20, 2004 · Not classified · Z-0519-05: 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.
- Dec 20, 2004 · Not classified · Z-0515-05: 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.
- Dec 20, 2004 · Not classified · Z-0517-05: 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.
- Dec 20, 2004 · Not classified · Z-0512-05: 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.
- Dec 20, 2004 · Not classified · Z-0513-05: 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.
- Dec 20, 2004 · Not classified · Z-0522-05: 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.
- Dec 20, 2004 · Not classified · Z-0516-05: 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.
- Dec 20, 2004 · Not classified · Z-0523-05: 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.
- Dec 20, 2004 · Not classified · Z-0499-05: 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.
- Dec 20, 2004 · Not classified · Z-0503-05: 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.
- Dec 20, 2004 · Not classified · Z-0500-05: 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.
- Dec 20, 2004 · Not classified · Z-0525-05: 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.
- Dec 20, 2004 · Not classified · Z-0518-05: 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.
- Dec 20, 2004 · Not classified · Z-0505-05: 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.
- Dec 20, 2004 · Not classified · Z-0506-05: 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.
- Dec 20, 2004 · Not classified · Z-0509-05: 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.
- Dec 20, 2004 · Not classified · Z-0511-05: 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.
- Dec 20, 2004 · Not classified · Z-0520-05: 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.
- Dec 20, 2004 · Not classified · Z-0501-05: 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.
- Dec 20, 2004 · Not classified · Z-0521-05: 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.

Source page: https://510kreport.com/device/P020018
Methodology: https://510kreport.com/methodology