HeartWare Ventricular Assist System Batteries - HSA Field Safety Notice

HSA Singapore issued a Field Safety Notice on June 4, 2026, regarding all HeartWare Ventricular Assist System batteries due to potential performance issues. Manufacturers' battery management and replacement instructions must be followed.

Source updated: Jun 4, 2026

Primary source: HSA

PV Impact Brief

Urgency: HighConfidence: high

What changed

HSA Singapore issued a Field Safety Notice for all HeartWare Ventricular Assist System batteries due to potential performance issues.

Why it matters

Battery performance issues in the HeartWare Ventricular Assist System could lead to device malfunction, posing serious risks to patients reliant on the system for cardiac support.

Action needed

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

Relevant for: Regulatory Intelligence LeadSignal Management Lead
Processes impacted: Signal ManagementLabeling
Owner: Regulatory Intelligence Lead
Review cadence: As needed per manufacturer updates or further HSA communications.

Regulatory action details

Action type: Field Safety Notice
Publication date: 2026-06-04
Safety issue: Field safety notice regarding all HeartWare Ventricular Assist System batteries, concerning potential performance issues.

Affected products

HeartWare Ventricular Assist System Batteries

PV internal implications

Healthcare providers and patients should follow the specific battery management and replacement instructions provided by the manufacturer.

View regulator source

Evidence and confidence

Confidence: highSource updated: Jun 4, 2026

HSA →Updated June 4, 2026

Full briefing

Practical implication

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

The Health Sciences Authority (HSA) of Singapore published a Field Safety Notice for HeartWare Ventricular Assist System batteries due to potential performance issues. Healthcare providers and patients are instructed to follow specific battery management and replacement instructions from the manufacturer.

What changed: HSA Singapore issued a Field Safety Notice for all HeartWare Ventricular Assist System batteries due to potential performance issues.

Why it matters: Battery performance issues in the HeartWare Ventricular Assist System could lead to device malfunction, posing serious risks to patients reliant on the system for cardiac support.

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

View original source

Published from the Firecrawl agent regulatory extraction pipeline.

#Safety Signals #HeartWare #Ventricular Assist System #Battery #Field Safety Notice #HSA #other #firecrawl-agent

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