PMA · Approved
Recalled · 2011Zenith Aaa Endovascular Graft and H&L-B One-Shot Introductino System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Approved on May 23, 2003 through premarket approval, which rests on the device’s own clinical evidence after a 364-day review. It has been recalled 111 times.
- Decided
- May 23, 2003
- Review
- 364 days
- Class
- Class III
- Product code
- MIH
- Recalls
- 111
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P020018 has 65 supplements since 2004: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
2004high 12 (2006) · low 0 (2015)2026
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2004 | 4 |
| 2005 | 2 |
| 2006 | 12 |
| 2007 | 3 |
| 2008 | 7 |
| 2009 | 3 |
| 2010 | 2 |
| 2011 | 3 |
| 2012 | 8 |
| 2013 | 2 |
| 2014 | 3 |
| 2016 | 2 |
| 2018 | 2 |
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 5 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 15, 2011 | Not classified | Z-3154-2011 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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. |
The 5 latest of 50 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MIH devicesMIH System, Endovascular Graft, Aortic Aneurysm Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MIH
50in 2025
2007high 80 (2014) · low 33 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · MIH
Too few MIH 510(k)s in any year since 2007 to give a median.
Recalls per year · MIH
1in 2025
2007high 29 (2011) · low 0 (2008)2026
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · MIH
3,302in 2025
2007high 4,471 (2015) · low 1,323 (2007)2025
MAUDE reports naming product code MIH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 33 | — | 1 | 1,323 |
| 2008 | 45 | — | 0 | 1,745 |
| 2009 | 49 | — | 0 | 2,600 |
| 2010 | 46 | — | 0 | 2,493 |
| 2011 | 64 | — | 29 | 3,241 |
| 2012 | 57 | — | 3 | 3,787 |
| 2013 | 48 | — | 0 | 3,883 |
| 2014 | 80 | — | 1 (1) | 4,249 |
| 2015 | 53 | — | 1 | 4,471 |
| 2016 | 47 | — | 6 | 4,296 |
| 2017 | 41 | — | 3 | 4,105 |
| 2018 | 39 | — | 4 (4) | 4,178 |
| 2019 | 34 | — | 0 | 3,592 |
| 2020 | 44 | — | 4 | 3,057 |
| 2021 | 50 | — | 4 | 3,686 |
| 2022 | 49 | — | 2 | 3,455 |
| 2023 | 50 | — | 0 | 3,562 |
| 2024 | 62 | — | 0 | 3,320 |
| 2025 | 50 | — | 1 (1) | 3,302 |
| 2026 | 35 | — | 2 (1) | — |
https://510kreport.com/device/P020018 · printed Nov 6, 2026
Cite this page
510(k) Report. “P020018: Zenith Aaa Endovascular Graft and H&L-B One-Shot Introductino System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P020018
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026