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Endologix LLC

United States·US-MF-000010201

Last updated September 17, 2026

What Endologix LLC makes

Endologix LLC manufactures aortoiliac endovascular stent-grafts, including bifurcated systems for abdominal aortic aneurysm repair, and vascular catheter introduction sets for procedural access. Their portfolio includes the AFX2 Bifurcated Endograft System and the Ovation iX Iliac Stent Graft, designed for endovascular treatment of aortic and iliac artery conditions.

The company’s devices are regulated under FDA 510(k) and PMA pathways (Class II/III) and listed in the FDA’s UDI database and EUDAMED registry. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Endologix LLC manufacture?

Endologix LLC specializes in aortoiliac endovascular stent-grafts, which are used primarily for repairing aneurysms in the aorta and iliac arteries. Their portfolio includes bifurcated endograft systems (like the AFX2) for abdominal aortic aneurysm (AAA) treatment and iliac stent grafts (such as the Ovation iX). They also produce vascular catheter introduction sets, which are nonimplantable devices used to facilitate procedural access in vascular interventions. These devices are designed to treat complex vascular conditions without open surgery.

Where is Endologix LLC based, and how does that affect its regulatory oversight?

Endologix LLC is based in the United States, which means its devices fall under FDA regulation. The company’s products are classified as Class II (moderate risk) or Class III (high risk), requiring premarket approval (PMA) or 510(k) clearance before commercialization. This classification ensures rigorous evaluation of safety and effectiveness before patient use, aligning with FDA requirements for high-risk medical devices.

Which regulatory registries list Endologix LLC’s devices, and why is this important?

Endologix LLC’s devices are listed in EUDAMED (the EU’s medical device registry) and the FDA’s UDI (Unique Device Identification) database, including 510(k) and PMA submissions. Listing in these registries ensures transparency and traceability, allowing healthcare providers, regulators, and patients to verify device details, compliance status, and manufacturing history. For example, EUDAMED helps EU authorities monitor post-market surveillance, while FDA’s UDI system supports recall tracking and device identification in the US.

How are Endologix LLC’s devices classified under medical device regulations?

Endologix LLC’s devices are classified as Class II or Class III under FDA regulations. Class III includes high-risk products like bifurcated endografts (e.g., AFX2), which require Premarket Approval (PMA) due to their critical role in treating life-threatening conditions like aortic aneurysms. Class II devices, such as vascular catheter introduction sets, undergo 510(k) clearance, demonstrating substantial equivalence to a legally marketed predicate device. This classification ensures appropriate scrutiny based on risk level.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 3910 Brickway Blvd, Santa Rosa, United States
Website: endologix.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: (949) 595-7200
PRRC Contact: Lisa Dierl
EUDAMED SRN: US-MF-000010201
FDA FEI Number: 3008011247
DUNS Number: 858560477

Catalogue (354)

Page 3 of 8

Device	Model / Reference	Registries	Class	Status
AFX Endovascular AAA System	I16-16/C55 SA	FDA UDI	Class III	Active
AFX2 Bifurcated Endograft System	BEA22-100/I20-55	FDA UDI	Class III	Active
Ovation iX Iliac Stent Graft	TV-IL141080-J	FDA UDI	Class III	Active
AFX2 Bifurcated Endograft System	BEA28-50/I16-30	FDA UDI	Class III	Active
AFX2 Bifurcated Endograft System	BEA22-90/I20-30	FDA UDI	Class III	Active
AFX Endovascular AAA System	BA25-80/I13-40	FDA UDI	Class III	Unknown
AFX Endovascular AAA System	A22-22/C75-O20	FDA UDI	Class III	Active
AFX Endovascular AAA System	A28-28/C75-O20	FDA UDI	Class III	Active
Ovation iX Iliac Stent Graft	TV-IL1416120-J	FDA UDI	Class III	Active
AFX2 Bifurcated Endograft System	BEA22-80/I16-55	FDA UDI	Class III	Active
AFX2 Bifurcated Endograft System	BEA25-80/I16-40	FDA UDI	Class III	Active
AFX Endovascular AAA System	IS20-25/C55 SA	FDA UDI	Class III	Active
Autoinjector 2	TV-AI01-N	FDA UDI	Class III	Active
AFX2 Bifurcated Endograft System	BEA28-40/I20-40	FDA UDI	Class III	Active
AFX2 Bifurcated Endograft System	BEA22-60/I16-40	FDA UDI	Class III	Active
AFX Endovascular AAA System	BA22-120/I13-40	FDA UDI	Class III	Unknown
AFX Endovascular AAA System	BA22-120/I20-40	FDA UDI	Class III	Unknown
Vela Proximal Endograft System	A31-31/C100 V	FDA UDI	Class III	Active
AFX2 Bifurcated Endograft System	BEA28-60/I20-40	FDA UDI	Class III	Active
AFX Endovascular AAA System	A34-34/C100-O20	FDA UDI	Class III	Active
AFX2 Bifurcated Endograft System	BEA25-70/I16-30	FDA UDI	Class III	Active
Ovation iX Iliac Stent Graft	TV-IL1418140-J	FDA UDI	Class III	Active
AFX Endovascular AAA System	BA25-60/I13-40	FDA UDI	Class III	Unknown
Ovation iX Iliac Stent Graft	TV-IL141880-J	FDA UDI	Class III	Active
AFX Endovascular AAA System	BA22-120/I16-40	FDA UDI	Class III	Unknown
AFX2 Bifurcated Endograft System	BEA28-80/I16-55	FDA UDI	Class III	Active
Vela Proximal Endograft System	A28-28/C75-O20 V	FDA UDI	Class III	Active
AFX2 Bifurcated Endograft System	BEA28-70/I20-30	FDA UDI	Class III	Active
AFX Endovascular AAA System	BA25-80/I16-55	FDA UDI	Class III	Unknown
Ovation iX Iliac Stent Graft	Iliac Limb	FDA UDI	Class III	Active
AFX2 Bifurcated Endograft System	BEA25-100/I13-40	FDA UDI	Class III	Active
Ovation iX Iliac Stent Graft	TV-IL141280-J	FDA UDI	Class III	Active
AFX2 Bifurcated Endograft System	BEA22-120/I16-40	FDA UDI	Class III	Active
Ovation iX Iliac Stent Graft	Iliac Limb	FDA UDI	Class III	Active
AFX Endovascular AAA System	A28-28/C95	FDA UDI	Class III	Active
AFX2 Bifurcated Endograft System	BEA25-100/I20-55	FDA UDI	Class III	Active
AFX2 Bifurcated Endograft System	BEA25-50/I20-30	FDA UDI	Class III	Active
AFX Endovascular AAA System	BA25-60/I20-40	FDA UDI	Class III	Unknown
AFX Endovascular AAA System	BA28-40/I13-40	FDA UDI	Class III	Unknown
Ovation iX Iliac Stent Graft	TV-IL1416140-J	FDA UDI	Class III	Active
Ovation iX Iliac Stent Graft	TV-EX161645-J	FDA UDI	Class III	Active
AFX Endovascular AAA System	I16-16/C88	FDA UDI	Class III	Unknown
Ovation iX Iliac Stent Graft	Iliac Limb	FDA UDI	Class III	Active
Vela Proximal Endograft System	A28-28/C95-O20 V	FDA UDI	Class III	Active
Vela Proximal Endograft System	A28-28/C75 V	FDA UDI	Class III	Active
AFX2 Bifurcated Endograft System	BEA25-120/I20-40	FDA UDI	Class III	Active
AFX Endovascular AAA System	BA28-120/I20-40	FDA UDI	Class III	Unknown
AFX Endovascular AAA System	BA28-40/I16-40	FDA UDI	Class III	Unknown
AFX Endovascular AAA System	BA22-110/I16-30	FDA UDI	Class III	Unknown
AFX2 Bifurcated Endograft System	BEA22-60/I13-40	FDA UDI	Class III	Active

Related Companies

Authorised Representatives

Endologix International Holdings B.V. NL

Importers

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Notified Bodies

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Authorities

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FDA Recalls (14)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Endologix LLC has 14 recall records initiated between December 14, 2005, and May 6, 2020, all marked as terminated. The reasons cited include reports of dilator breakage, detachment of polyimide tubing from the inner core of delivery catheters, and potential polymer leaks during pressurization of abdominal stent graft systems. Specific incidents involved separation of the front sheath or catheter components, which may affect deployment or cause temporary interruptions in treatment.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
May 6, 2020	Z-2263-2020	—	terminated	A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Polymer leaks may occur during implantation of abdominal stent graft system. Clinical events related to polymer leaks may be systemic and/or aneurysm related.
May 13, 2013	Z-1436-2013	—	terminated	Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures.
Nov 25, 2009	Z-0594-2010	—	terminated	This action is being taken because the product has the potential for the polyimide tubing to detach from the inner core due to the bond failure. If this occurs, treatment may be delayed or interrupted. The firm's initial health hazard analysis indicated the event may cause temporary or medically reversible adverse health consequences or an outcome where the probability of serious adverse health
Nov 25, 2009	Z-0593-2010	—	terminated	This action is being taken because the product has the potential for the polyimide tubing to detach from the inner core due to the bond failure. If this occurs, treatment may be delayed or interrupted. The firm's initial health hazard analysis indicated the event may cause temporary or medically reversible adverse health consequences or an outcome where the probability of serious adverse health c
Nov 8, 2006	Z-0309-2007	—	terminated	Recall was initiated after a clinical incident involving separation of the front sheath, preventing deployment of the stent graft. This required the physician to convert the patient to conventional open repair.
Nov 8, 2006	Z-0310-2007	—	terminated	Recall was initiated after a clinical incident involving separation of the front sheath, preventing deployment of the stent graft. This required the physician to convert the patient to conventional open repair.
Dec 14, 2005	Z-0593-06	—	terminated	The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.
Dec 14, 2005	Z-0591-06	—	terminated	The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.
Dec 14, 2005	Z-0595-06	—	terminated	The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.
Dec 14, 2005	Z-0590-06	—	terminated	The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.
Dec 14, 2005	Z-0589-06	—	terminated	The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.
Dec 14, 2005	Z-0594-06	—	terminated	The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.
Dec 14, 2005	Z-0596-06	—	terminated	The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.
Dec 14, 2005	Z-0592-06	—	terminated	The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.