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Early Alert: Thoracic Stent Graft Issue from Bolton Medical
The FDA is aware that Bolton Medical has issued an Urgent Medical Device Recall (Correction) notice providing updated use instructions for all Relay Pro Thoracic Stent Graft System, N4: Non-Bare Stent Configuration 32mm and above. The notice also recommends customers consider using alternative stent-graft options prior to use of impacted RelayPro devices until mitigation measures are in place.