Alto™ Abdominal Stent Graft System
Endologix LLC · Model TV-AB2680-N · UDI-DI 00850007370893
Description
"The Alto™ Abdominal Stent Graft System is an endovascular device delivered via a low-profile catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high-pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required. The Alto™ Abdominal Stent Graft System includes: an Aortic Body Stent Graft and delivery catheter, Ovation iX™ Iliac Limb Stent Grafts and delivery catheters, Ovation iX™ Iliac Extension Stent Grafts and delivery catheters (as required), the CustomSeal™ Polymer Fill Kit, and the Autoinjector 2."
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. | Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docs