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MEDICAL DEVICE RECALLCRITICAL
RelayPro Thoracic Stent-Graft System
Bolton Medical is recalling 100+ variants of the RelayPro Thoracic Stent-Graft System due to a potential delivery system release failure.
What to do
Healthcare providers should immediately quarantine any remaining inventory of the affected RelayPro Thoracic Stent-Graft System and contact Bolton Medical for return instructions. Do not use the affected devices.
Why it was recalled
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
How to identify it
RelayPro Thoracic Stent-Graft System (various sizes)
Official source
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Editorial summary by Recall Canary · last updated 2026-05-23 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification