Recall Z-2160-2026 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Bolton Medical Inc.
RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-34-109-34U 28-N4-34-154-30U 28-N4-34-154-34U 28-N4-34-209-30U 28-N4-34-209-34U 28-N4-34-259-34U 28-N4-36-109-36U 28-N4-36-154-32U 28-N4-36-154-36U 28-N4-36-199-32U 28-N4-36-199-36U 28-N4-36-259-36U 28-N4-38-109-38U 28-N4
| Date | May 22, 2026 (initiated Apr 22, 2026) |
| Status | Open, Classified |
| Reason | Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system. |
| Root cause | Under Investigation by firm |
| Action | On June 15, 2026, Bolton Medical Inc. (subsidiary of Terumo Aortic) issued a 3rd iteration of the Urgent Medical Device Recall (Removal) notification via overnight mail. The updated communication contained a revised "Action to be taken" section as well as acknowledgment form. Initial notification was sent on April 22, 2026. and a 2nd iteration was issued on May 5, 2026, a 2nd iteration was issued updating the recall strategy to removal. Bolton Medical ask consignees to take the following actions: 1. Discontinue use of the Relay Pro immediately. 2. Review your Relay Pro Inventory and immedi |
| Distribution | Worldwide - distribution in the US Territory of Puerto Rico and the countries of Argentina, Chile, Canada, Colombia, Mexico, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.