Home › Endologix LLC › Autoinjector 2
Autoinjector 2
Endologix LLC · Model TV-AI01-N · UDI-DI 00850007370398
MIH
Prescription
0
510(k) clearances
72,311
Adverse events (7,103 deaths)
176
Recalls
34
Facilities
Description
"The Autoinjector 2 is a component of the Alto™ Abdominal Stent Graft System. The Autoinjector 2 applies controlled force to the syringe plunger of the CustomSeal Kit to inject the fill polymer into the graft until pressure equilibrium is reached and complete fill of the primary sealing ring, fill channels, and support rings in the graft material the of the aortic body is achieved."
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 docsData 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.