Home › Device types › MIH
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA product code MIH · Class 3 · Unknown
5,543
Registered devices
71,804
Adverse events
176
Recalls
0
510(k) clearances
Devices with this code
Aorfix AAA Stent Graft Body with Aorflex Delivery System — LOMBARD MEDICAL LIMITEDRelayPro Thoracic Stent-Graft System — Bolton Medical Inc.Zenith Alpha — William Cook Europe ApSZenith Flex — COOK INCORPORATEDRelayPro Thoracic Stent-Graft System — Bolton Medical Inc.RelayPro Thoracic Stent-Graft System — Bolton Medical Inc.RelayPro Thoracic Stent-Graft System — Bolton Medical Inc.GORE EXCLUDER Iliac Branch Endoprosthesis — W. L. Gore & Associates, Inc.Zenith Renu — COOK INCORPORATEDRelayPro Thoracic Stent-Graft System — Bolton Medical Inc.RelayPro Thoracic Stent-Graft System — Bolton Medical Inc.TALENT™ ABDOMINAL — MEDTRONIC, INC.Zenith — WILLIAM A. COOK AUSTRALIA PTY. LTD.Zenith Spiral-Z — COOK INCORPORATEDRelay Plus Thoracic Stent-Graft System — Bolton Medical Inc.RelayPro Thoracic Stent-Graft System — Bolton Medical Inc.Aorfix AAA Stent Graft Body with Aorflex Delivery System — LOMBARD MEDICAL LIMITEDEndurant® II — MEDTRONIC, INC.Valiant Navion™ — MEDTRONIC, INC.VALIANT® Captivia — MEDTRONIC, INC.RelayPro Thoracic Stent-Graft System — Bolton Medical Inc.Relay Plus Thoracic Stent-Graft System — Bolton Medical Inc.Zenith Alpha — William Cook Europe ApSZenith — WILLIAM A. COOK AUSTRALIA PTY. LTD.
Recent 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 t |
| 2021-10-15 | Medtronic Vascular, Inc. | 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. |
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