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Ovation iX Iliac Stent Graft

Endologix LLC · Model TV-IL1418120-J · UDI-DI 00850007370299

MIH Prescription

510(k) clearances

72,311

Adverse events (7,103 deaths)

176

Recalls

Facilities

Description

The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Limbs are comprised of a nitinol stent encapsulated in low-permeability PTFE. The iliac limbs are deployed into the leg sections of the aortic body. Additional iliac limbs may be used to extend the length of the device, where indicated.

Recalls

Date	Firm	Reason
2026-05-19	W L Gore & Associates, Inc.	Due to catheter separation
2026-04-22	Bolton Medical Inc.	Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
2025-09-18	Cook Medical Incorporated	Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
2024-02-22	Bolton Medical Inc.	The stent-graft inside the delivery system was the incorrect size.
2023-05-03	Bolton Medical Inc.	Potential for the incorrect size stent-graft than the printed carton label.
2022-12-20	Bolton Medical Inc.	The product may be shorter than packaging indicates
2022-12-20	Bolton Medical Inc.	The product may be shorter than packaging indicates
2021-12-21	Medtronic Vascular, Inc.	Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during
2021-10-15	Medtronic Vascular, Inc.	Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
2021-10-15	Medtronic Vascular, Inc.	During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.