RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, s

FDA device recall Z-1383-2024 · posted 2024-03-27 · Completed

Recall details

Recalling firm

Bolton Medical Inc.

Reason for recall

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Completed

Product code

MIH

Quantity affected

21 devices

Distribution

Worldwide - US Nationwide distribution in the states of AZ, MA, and TX. The countries of Chile, France, Germany, Italy, Japan, Poland, Spain, and Thailand.

Date initiated

2024-02-22

Date posted

2024-03-27

Location

Sunrise, FL