Recall Z-1383-2024 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Bolton Medical Inc.
RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part number 28-M4-34-100-34U; (b) Part number 28-M4-30-095-30U; (c) Part number 28-M4-46-155-46U; (d) Part number 28-M4-32-155-32S; (e) Part number 28-M4-36-250-32S; (f) Part number 28-M4-38-145-34S; (g) Part number 28-M4-38-190-38S; (h) Part number 28-M4-44-105-44S;
| Date | Mar 27, 2024 (initiated Feb 22, 2024) |
| Status | Completed |
| Reason | The stent-graft inside the delivery system was the incorrect size. |
| Root cause | Under Investigation by firm |
| Action | 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 informa |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.