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U.S. Department of Health and Human Services

Class 2 Device Recall RELAY PRO Thoracic StentGraft System

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  Class 2 Device Recall RELAY PRO Thoracic StentGraft System see related information
Date Initiated by Firm February 22, 2024
Date Posted March 27, 2024
Recall Status1 Completed
Recall Number Z-1383-2024
Recall Event ID 93873
PMA Number P200045 
Product Classification System, endovascular graft, aortic aneurysm treatment - Product Code MIH
Product 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;
(i) Part number 28-N4-22-099-22S;
(j) Part number 28-N4-22-159-22S;
(k) Part number 28-N4-24-099-24S;
(l) Part number 28-N4-28-204-24S
(m) Part number 28-N4-30-164-30U;
(n) Part number 28-N4-32-164-28S;
(o) Part number 28-N4-34-154-34U;
(p) Part number 28-N4-34-209-30S;
(q) RELAY PRO Custom-Made Device, REF 28NC36N19038S2590, part number 28-CMP-3062-NC; and
(r) RELAY PRO Custom-Made Device, REF 28MC36A17536S2390, part number 28-CMP-3074-MC;
Code Information (a) Part number 28-M4-34-100-34U - Lot #2112080111 and #2112080158, UDI 843576149656; (b) Part number 28-M4-30-095-30U - Lot #2112080147 and #2112080148, UDI 843576149632; (c) Part number 28-M4-46-155-46U - Lot #2112100328, UDI 843576149847; (d) Part number 28-M4-32-155-32S - Lot #B211209120, UDI 843576100183; (e) Part number 28-M4-36-250-32S - Lot #B211203197, UDI 843576100763; (f) Part number 28-M4-38-145-34S - Lot #B211206395, UDI 843576100572; (g) Part number 28-M4-38-190-38S - Lot #B211202319, UDI 843576100343; (h) Part number 28-M4-44-105-44S - Lot #B211209068, UDI 843576100114; (i) Part number 28-N4-22-099-22S - Lot #B211208120, UDI 843576100824; (j) Part number 28-N4-22-159-22S - Lot #B211208162, UDI 843576100954; (k) Part number 28-N4-24-099-24S - Lot #B211130071 and #B211207227, UDI 843576100831; (l) Part number 28-N4-28-204-24S - Lot #B211209065, UDI 843576101449; (m) Part number 28-N4-30-164-30U - Lot #2112100333, UDI 843576150584; (n) Part number 28-N4-32-164-28S - Lot #B211207181, UDI 843576101364; (o) Part number 28-N4-34-154-34U - Lot #2112090117, UDI 843576150607; (p) Part number 28-N4-34-209-30S - Lot #B211209073, UDI 843576101470; (q) Part number 28-CMP-3062-NC - Lot #2112100385, no UDI; and (r) Part number 28-CMP-3074-MC - Lot #2112100383, no UDI;
Recalling Firm/
Manufacturer		 Bolton Medical Inc.
799 International Pkwy
Sunrise FL 33325-6220
For Additional Information Contact Megan Indeglia
954-626-5122
Manufacturer Reason
for Recall		 The stent-graft inside the delivery system was the incorrect size.
FDA Determined
Cause 2		 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 information contained in the letter, has taken the appropriate action, and disseminated the information to any affected staff, service, and/or facilities.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MIH and Original Applicant = Bolton Medical, Inc.
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