Recall Z-1383-2024— Bolton Medical Inc.

Class II FDA medical device recall by Bolton Medical Inc., initiated 2024-02-22. 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;. Reason: The stent-graft inside the delivery system was the incorrect size..

Recalling firm

Bolton Medical Inc.

Classification

Class II

Status

Completed

Initiated

2024-02-22

Firm location

Sunrise, FL, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.