Tag archive

HSA

publicHSA · Singapore · Updated Jun 4, 2026

HeartWare Ventricular Assist System Batteries - HSA Field Safety Notice

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

publicHSA · Singapore · Updated Jun 4, 2026

Urgent Field Action Notification of Advanced Bionics HiRes Ultra / Ultra 3D

Urgency: High

Healthcare providers must notify patients of potential device performance issues and monitor for any device failure or reduced performance signs.

Signal ManagementLabelingRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, Signal Management Lead

verifiedRegulatory action: Urgent Field Action

Read impact briefarrow_forward

Get updates for your PV role

Subscribe to impact-first pharmacovigilance updates. Select every role you want in your digest.

Digest roles: QPPV. Work email only