FDA Recall Open, Classified

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-N4-38-154-34U 28-N4-38-154-38U 28-N4-38-199-34U 28-N4-38-199-38U 28-N4-38-259-38U 28-N4-40-114-40U 28-N4-40-154-36U 28-N4-40-154-40U 28-N4-40-204-36U 28-N4-40-204-40U 28-N4-40-259-40U 28-N4-42-114-42U 28-N4-42-159-38U 28-N4-42-159-42U 28-N4-42-204-38U 28-N4-42-204-42U 28-N4-42-259-42U 28-N4-44-114-44U 28-N4-44-164-40U 28-N4-44-164-44U 28-N4-44-209-40U 28-N4-44-209-44U 28-N4-44-259-40U 28-N4-44-259-44U 28-N4-46-114-46U 28-N4-46-164-42U 28-N4-46-164-46U 28-N4-46-209-42U 28-N4-46-209-46U 28-N4-46-259-42U

Recall: Z-2160-2026 · Initiated April 22, 2026

Recall

Recall Number: Z-2160-2026
Event Number: 98729
Firm: Bolton Medical Inc.
FEI Number: 1000135961
Product Code: MIH
Status: Open, Classified
Root Cause: Under Investigation by firm
Initiated: April 22, 2026
Posted: May 22, 2026
Address: 799 International Pkwy, Sunrise, FL, 33325-6220

Description

Reason

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

Action

On April 22, 2026 Bolton Medical Inc. (subsidiary of Terumo Aortic). Bolton Medical ask consignees to take the following actions: 1. Consider alternative stent-graft options prior to use of the RelayPro devices impacted until the root cause evaluation is completed and effective mitigation measures are in place. 2. Inform all users of Relay Pro of the additional guidance for managing cases where the stent graft cannot be released from the delivery system. 3. Please post a copy of this notification where the devices are stored and keep with the IFU. 4. Complete acknowledgment form acknowledging receipt and communication of this medical device correction notice. Return to [email protected]. 5. If devices have been transferred to another facility, please provide them with a copy of the notification and instruct them to follow the actions in this section.

Distribution

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