Tag archive

Field Safety Notice

publicMedicines and Healthcare products Regulatory Agency (MHRA) · United Kingdom · Updated Jun 8, 2026

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

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

Signal ManagementLabelingRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, Signal Management Lead

verifiedRegulatory action: Field Safety Notice (FSN)

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publicHSA · Singapore · Updated Jun 4, 2026

HeartWare Ventricular Assist System Batteries - HSA Field Safety Notice

Urgency: High

Identify and quarantine affected HeartWare batteries; follow manufacturer's instructions for battery management and replacement; ensure patients and healthcare providers are informed.

Signal ManagementLabelingRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, Signal Management Lead

verifiedRegulatory action: Field Safety Notice

Read impact briefarrow_forward

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