RELAY PRO Stent-Graft (Bolton Medical) – Incorrect Size (2024)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The stent-graft inside the delivery system was the incorrect size.

Recommended Action

Per FDA guidance

The firm issued letters dated and issued on 2/22/2024 via certified mail to it's U.S. customers. For OUS customers, the letters will be issued by 3/8/2024 due to the need to translate the letters into their local languages. The letter explained the reason for recall, risk to health, and actions to be taken by the customer/user. The instructions included completing the Acknowledgement Form, retaining a copy of it, and informing Terumo Aortic of any adverse events concerning the use of the affected product. The Acknowledgement Form indicates the consignee has read and understands the information contained in the letter, has taken the appropriate action, and disseminated the information to any affected staff, service, and/or facilities.