RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-3

FDA device recall Z-2160-2026 · posted 2026-05-22 · Open, Classified

Recall details

Recalling firm

Bolton Medical Inc.

Reason for recall

Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.

Action taken

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 immediately isolate affected inventory to prevent future use. 3. If devices have been transferred to another facility, please provide them with a copy of this notification and instruct them to follow the actions in this section. 4. Complete the acknowledgment form indicating the number of units in your control to be returned to Terumo. The form is required even if you do not have product on hand. 6. Return affected product to the address below using the enclosed prepaid UPS return label and include a copy of Appendix 1 as the packing slip with your physical product return. For shipping assistance or additional labels, please call Sedgwick at 888-719-5830. Sedgwick, Inc.; Attn: Event 6732, 2670 Executive Dr., Suite A, Indianapolis, IN 46241.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MIH

Distribution

Worldwide - distribution in the US Territory of Puerto Rico and the countries of Argentina, Chile, Canada, Colombia, Mexico, United Kingdom.

Date initiated

2026-04-22

Date posted

2026-05-22

Location

Sunrise, FL