Primary source: Medicines and Healthcare products Regulatory Agency (MHRA)
MHRA published a field safety notice for the RelayPro Thoracic Stent-Graft System (NBS) on 8 June 2026, detailing required user actions.
This FSN indicates a potential safety issue with the device that may impact patient safety and requires prompt attention from users to mitigate risk.
Verify inventory of affected RelayPro Thoracic Stent-Graft System lots (model 28-N4-XX-XXX-XXS) and implement actions per the FSN document.
Regulatory Intelligence Lead
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Users should follow the specific actions provided in the FSN document for the RelayPro system.
Verify inventory of affected RelayPro Thoracic Stent-Graft System lots (model 28-N4-XX-XXX-XXS) and implement actions per the FSN document.
MHRA field safety notice (reference 39747013) for the RelayPro Thoracic Stent-Graft System (NBS) from Bolton Medical instructs users to follow the outlined corrective actions.
What changed: MHRA published a field safety notice for the RelayPro Thoracic Stent-Graft System (NBS) on 8 June 2026, detailing required user actions.
Why it matters: This FSN indicates a potential safety issue with the device that may impact patient safety and requires prompt attention from users to mitigate risk.
Practical implication: Verify inventory of affected RelayPro Thoracic Stent-Graft System lots (model 28-N4-XX-XXX-XXS) and implement actions per the FSN document.
Published from the Firecrawl agent regulatory extraction pipeline.
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