Product code MIH ยท Class 3
System, Endovascular Graft, Aortic Aneurysm Treatment
0510(k)s in 12 months (0 all time)
2recalls in 12 months (176 all time)
0recalls that name a 510(k)
Top companies in MIH
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Inc. | 0 | 121 |
| Endologix | 0 | 23 |
| Medtronic Vascular, Inc. | 0 | 11 |
| W L Gore & Associates, Inc. | 0 | 7 |
| Bolton Medical Inc. | 0 | 5 |
| Trivascular, Inc | 0 | 3 |
| Cook Medical Incorporated | 0 | 2 |
| W L Gore & Assoc, Inc. | 0 | 2 |
| Bard Peripheral Vascular Inc | 0 | 1 |
| Medtronic CardioVascular | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2026 | W L Gore & Associates, Inc. GORE TAG Thoracic Branch Endoprosthesis Side Branch Component
Catalog Numbers (by Region)
United States (includes Puerto Rico) and Canada:
TSB080806A, TSB081006A, TSB081206A,
TSB081506A, TSB081706A, T Open, Classified |
MIH | None listed |
| May 22, 2026 | Bolton Medical Inc. RelayPro Thoracic Stent-Graft System (various sizes)
Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-34-109-34U 28-N4-34- Open, Classified |
MIH | None listed |
| Oct 10, 2025 | Cook Medical Incorporated Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2-
Reference Part Numbers
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- Open, Classified |
MIH | None listed |
| Mar 27, 2024 | Bolton Medical Inc. RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile:
(a) Part number 28-M4-34-100-34U;
(b) Part number 28-M4-30-095-30U;
(c) Completed |
MIH | None listed |
| Jun 6, 2023 | Bolton Medical Inc. The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graft and a Straight Ili Open, Classified |
MIH | None listed |
| Jan 19, 2023 | Bolton Medical Inc. RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX Open, Classified |
MIH | None listed |
| Jan 19, 2023 | Bolton Medical Inc. RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX Open, Classified |
MIH | None listed |
| Dec 21, 2021 | Medtronic Vascular, Inc. Endurant, Endurant II and Endurant IIs Stent Graft System:
Medtronic Endurant Stent Graft System Model/REF
ENBF2313C120EE;
ENBF2313C120EE;
ENBF2313C145EE;
ENBF2313C170EE;
ENBF2316C120EE;
ENBF2316C145 Open, Classified |
MIH | None listed |
| Oct 15, 2021 | Medtronic Vascular, Inc. Endurant IIs Stent Graft System
REF/Description:
ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF
ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF
ESBF2814C103EE STENT GRAFT ESBF2814C103 Open, Classified |
MIH | None listed |
| Oct 15, 2021 | Medtronic Vascular, Inc. Endurant II Stent Graft System
REF/Description:
ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF
ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF
ETBF2820C166EE STENT GRAFT ETBF2820C166EE Open, Classified |
MIH | None listed |
| Oct 15, 2021 | Medtronic Vascular, Inc. Endurant Stent Graft System
REF/Description:
ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE Open, Classified |
MIH | None listed |
| Jun 7, 2021 | Medtronic Vascular, Inc. Medtronic Endurant IIs Stent Graft System
Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E.
Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using a Open, Classified |
MIH | None listed |
| Jun 7, 2021 | Medtronic Vascular, Inc. Endurant II/Endurant IIs Stent Graft System:
Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E.
Used to treat infrarenal abdominal aort Open, Classified |
MIH | None listed |
| Apr 28, 2021 | Medtronic Vascular, Inc. Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms. Terminated |
MIH | None listed |
| Feb 12, 2021 | Medtronic Vascular, Inc. Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA). Open, Classified |
MIH | None listed |
| Sep 9, 2020 | W L Gore & Associates, Inc. GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System Open, Classified |
MIH | None listed |
| Sep 9, 2020 | W L Gore & Associates, Inc. GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System Open, Classified |
MIH | None listed |
| Aug 11, 2020 | Cook Inc. Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only.
Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms
Reference Part Number (RPN):
ZIMB Terminated |
MIH | None listed |
| Jun 11, 2020 | Endologix, Inc. Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB2680-J, TV-AB2980-I, TV-AB2980-J, TV-AB3480-I, TV-AB3480-J Terminated |
MIH | None listed |
| Jun 2, 2020 | Cook Inc. Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morpholog Terminated |
MIH | None listed |
| May 20, 2020 | W L Gore & Associates, Inc. Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta. Terminated |
MIH | None listed |
| Jan 31, 2020 | Cook Inc. Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft. Terminated |
MIH | None listed |
| Jan 6, 2020 | W. L. Gore & Associates Inc. GORE EXCLUDER Iliac Branch Endoprosthesis
(IBE) Terminated |
MIH | None listed |
| Jan 6, 2020 | W. L. Gore & Associates Inc. GORE EXCLUDER AAA Endoprosthesis Terminated |
MIH | None listed |
| Jun 19, 2019 | Cook Inc. Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24 Terminated |
MIH | None listed |
| Oct 3, 2018 | Endologix ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX Limb Accessory Model #/REF:
I16-16/C55,
I16-16/C55F,
I16-16/C88,
I20-13/C70F,
I20-13/C88F,
I16-16/C55 Terminated |
MIH | None listed |
| Oct 3, 2018 | Endologix ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO,
AFX Proximal Accessory,
Infrarenal Model #/REF:
A22-22/C55,
A22-22/C75,
A22-22/C95,
A25-25/C55, Terminated |
MIH | None listed |
| Oct 3, 2018 | Endologix ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile EO, REF:
BEA22-120/I20-40,
BEA22-100/I20-40,
BEA22-80/I20-40,
BEA22-60/I20-40,
BEA22-40/I20-4 Terminated |
MIH | None listed |
| Oct 3, 2018 | Endologix ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, REF:
BA22-120/I20-40,
BA22-100/I20-40,
BA22-80/I20-40,
BA22-60/I20-40, Terminated |
MIH | None listed |
| Oct 25, 2017 | W L Gore & Associates, Inc. GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE.
The GORE TAG Thoracic Endoprosthesis is intended
for endovascular repair of all lesions of the descending
thoracic aorta. Terminated |
MIH | None listed |
| Aug 10, 2017 | Cook Medical Incorporated 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 Terminated |
MIH | None listed |
| Mar 15, 2017 | Medtronic Vascular, Inc. Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems
Model Numbers:
ETBF2516C145E
ETBF2516C166E
ETBF2316C145E
ETBF2313C145E
ETBF2513C166E
ETBF2313C166E
ETBF2316C166E
ETBF2313C124E
ETBF Terminated |
MIH | None listed |
| Jan 19, 2017 | Endologix AFX2 Endovascular AAA System
Item No. Item Description
F00820-01 BEA28-120/I20-40
F00820-02 BEA28-100/I20-40
F00820-03 BEA28-80/I20-40
F00820-06 BEA28-120/I16-40
F00820-07 BEA28-100/I16-40
F008 Terminated |
MIH | None listed |
| Jan 19, 2017 | Endologix AFX Endovascular AAA System
Item Number Item Description
F0070305 A2525/C75 V
F0070308 A2828/C75 V
F0070312 A3434/C80 V
f00553 Terminated |
MIH | None listed |
| Jan 19, 2017 | Endologix AFX Endovascular AAA System, Endoleak Type: IIIB
Common Name: AFX Bifurcated and Accessory Stent Grafts
Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
The AFX Endovascula Terminated |
MIH | None listed |
| Jan 19, 2017 | Endologix AFX Endovascular AAA System, Endoleak Type IIIA
Product Usage:
The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA). Terminated |
MIH | None listed |
| Jan 19, 2017 | Endologix AFX Endovascular AAA System, Endoleak Type IIIB
Common Name: AFX Bifurcated and Accessory Stent Grafts
Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment Terminated |
MIH | None listed |
| Jan 18, 2017 | Endologix AFX Endovascular AAA System, Endoleak Type IIIB;
The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA). Terminated |
MIH | None listed |
| Jan 18, 2017 | Endologix AFX Endovascular AAA System, Endoleak Type IIIA
Common Name: AFX Bifurcated and Accessory Stent Grafts
Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
The AFX Endovascular Terminated |
MIH | None listed |
| Jan 18, 2017 | Endologix AFX Endovascular AAA System, Endoleak Type IIIA Terminated |
MIH | None listed |
| Nov 5, 2015 | Bard Peripheral Vascular Inc FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm
The FLAIR Endovascular Stent Graft (implant) is a flexible, self-expanding endoprosthesis comprised of expanded Terminated |
MIH | None listed |
| Nov 3, 2014 | Trivascular, Inc Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts.
The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device delivered via catheter to t Terminated |
MIH | None listed |
| Mar 26, 2014 | Trivascular, Inc Ovation Prime Abdominal Stent Graft System;
Manufacturer:
TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa, CA 95403
The TriVascular Ovation Prime Abdominal Stent Graft System is an endovascular devi Terminated |
MIH | None listed |
| Oct 25, 2013 | Medtronic Vascular, Inc. Valiant Thoracic Stent Graft with Captivia Delivery System,
Talent Thoracic Stent Graft with the Captivia Delivery System. Terminated |
MIH | None listed |
| Nov 13, 2012 | Trivascular, Inc TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributor inventory only);
PRODUCT Usage:
The TriVascular Ovation Terminated |
MIH | None listed |
| Mar 23, 2012 | Medtronic Vascular, Inc. Talent Captivia Stent Graft System - FreeFlow configurations only.
Model numbers affected have the following designation:
TFXXXXXXXXCP and TBXXXXXXXXCP.
Medtronic Inc.
Santa Rosa, CA 95403.
The Talen Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-32-39, REF G32184, 20 Fr. ID/ 7.7 mm OD, Sterile. Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-30-39, REF G32183, 20 Fr. ID/ 7.7 OD, Sterile. Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-22-29, REF G32179, 18 Fr. ID/ 6.90 OD, Sterile. Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-24-90-ZT, REF G48479, 16 Fr. ID/ 6.0 OD, Sterile. Terminated |
MIH | None listed |
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