Open official notice

Market recall and safety warnings concerning certain models and serial numbers of HeartSine Samaritan PAD automated external defibrillators due to 3 potential problems identified

Official notice

9 Oct 2026

Last checked

8 Nov 2026

RecallScope risk estimate:HighAEMPS

An official AEMPS notice concerns Market recall and safety warnings concerning certain models and serial numbers of HeartSine Samaritan PAD automated external defibrillators due to 3 potential problems identified. Market recall and safety warnings concerning certain models and serial numbers of HeartSine Samaritan PAD automated external defibrillators due to 3 potential problems identified: - Possibility that the intended therapy may not be delivered due to a manufacturing defect involving a circuit board component. - A problem involving the membrane tab, an internal component that could cause the device to stop working. - Absence of a supplement containing routine maintenance instructions. Published 2026-10-09.

What to do now

AEMPS recommends that those responsible for HeartSine Samaritan PAD defibrillators affected by the product failure problems have an alternative automated external defibrillator available until Stryker provides a replacement defibrillator unaffected by the problem arising during the manufacturing process, as the affected defibrillators may not deliver the necessary therapy in an emergency.

Recall number

2026-496

Official notice

2026-10-09

The hazard

Market recall and safety warnings concerning certain models and serial numbers of HeartSine Samaritan PAD automated external defibrillators due to 3 potential problems identified: - Possibility that the intended therapy may not be delivered due to a manufacturing defect involving a circuit board component. - A problem involving the membrane tab, an internal component that could cause the device to stop working. - Absence of a supplement containing routine maintenance instructions.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Check the official notice for the affected products and next steps.

Other

PS/PRV/143663

Models

SAM 350P, SAM 360P, SAM 450P, SAM 500P

Recall Numbers

2026-496

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Affected products

Product 1

Desfibriladores automáticos externos HeartSine Samaritan PAD

Hazard

Market recall and safety warnings concerning certain models and serial numbers of HeartSine Samaritan PAD automated external defibrillators due to 3 potential problems identified: - Possibility that the intended therapy may not be delivered due to a manufacturing defect involving a circuit board component. - A problem involving the membrane tab, an internal component that could cause the device to stop working. - Absence of a supplement containing routine maintenance instructions.

Where it was sold

Retailer information is not currently available in RecallScope. Check the official notice for distribution details.

Location 1

ES · Spain

Affected area 1

ES · Spain

Source & status

Source

Tier

official

Category

HEALTH

Official classification

AEMPS — Alerta de vigilancia de productos sanitarios (tipo 2A)

Recall details

Recall number

2026-496

Event id

2026-496

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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