PV Bulletin

Field Safety Notice: Bolton Medical RelayPro Thoracic Stent-Graft System (NBS)

MHRA issued field safety notice for Bolton Medical RelayPro Thoracic Stent-Graft System (model 28-N4-XX-XXX-XXS) requiring users to follow specific actions in the FSN document.

Primary source: Medicines and Healthcare products Regulatory Agency (MHRA)

PV Impact Brief

Urgency: HighConfidence: high

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.

Action needed

Verify inventory of affected RelayPro Thoracic Stent-Graft System lots (model 28-N4-XX-XXX-XXS) and implement actions per the FSN document.

Relevant for
Regulatory Intelligence LeadSignal Management Lead
Processes impacted
Signal ManagementLabeling
Owner

Regulatory Intelligence Lead

Review cadence

weekly

Regulatory action details

Action type
Field Safety Notice (FSN)
Publication date
2026-06-08
Safety issue
Field safety notice regarding the RelayPro Thoracic Stent-Graft System (NBS), MHRA reference 39747013.

Affected products

  • RelayPro Thoracic Stent-Graft System (NBS)
    Bolton Medical

PV internal implications

Users should follow the specific actions provided in the FSN document for the RelayPro system.

View regulator source

Evidence and confidence

Confidence: highSource updated: Jun 8, 2026

Full briefing

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.

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.

View original source

Published from the Firecrawl agent regulatory extraction pipeline.

#MHRA#Other#Medicines and Healthcare products Regulatory Agency (MHRA)#Field Safety Notice#Medical Device#Stent-Graft#Bolton Medical#Field Safety Notice (FSN)

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