HeartSine AED Devices Recalled in Canada Over Missing Maintenance Guide

Health Canada has issued a recall notice for several models of HeartSine samaritan PAD automated external defibrillators after manufacturer Stryker discovered that a limited number of units were distributed without a required maintenance supplement. The missing document contains periodic maintenance instructions considered an additional risk-control measure for the life-saving cardiac devices.

What Products Are Being Recalled?

The recall covers the HeartSine samaritan PAD SAM 350P, SAM 360P, and SAM 500P models. Affected catalogue numbers include 360-BAS-CN-10, 360-BAS-CF-10, 360-TSO-CN-10, 500-STR-CN-10, 500-BAS-CN-10, 500-BAS-CF-10, 350-TSO-CN-10, 350-BAS-CN-10, 350-BAS-CF-10, and 350-STR-CN-10. According to Health Canada, more than 10 lot or serial numbers are involved, and affected consumers must contact the manufacturer directly to confirm whether their specific unit is impacted.

Why Was This Recall Issued?

Stryker identified that a limited number of HeartSine samaritan PAD devices were distributed without the required maintenance supplement, which outlines periodic maintenance instructions implemented as an added safety measure. While most devices already include this supplement, the correction is being carried out voluntarily to make sure every end user has access to the supplemental maintenance information. The issue came to light after a customer complaint was filed with the company.

Who Is Affected?

This recall is classified by Health Canada as a Type II health product recall, primarily targeting the industry audience, including distributors, healthcare facilities, and organizations that purchased or maintain these defibrillators. HeartSine devices are widely used in workplaces, public buildings, and emergency response settings, so any organization or individual responsible for maintaining one of these units should check whether their device is included.

What Should You Do?

Owners and operators of HeartSine samaritan PAD SAM 350P, 360P, or 500P units should contact the manufacturer, Heartsine Technologies, Ltd., directly to determine whether their specific device lot or serial number is affected and to request the missing maintenance supplement. No product return, refund, or physical repair is required as part of this correction; the issue relates solely to missing labelling and maintenance documentation. Consumers and organizations can also report any related health or safety concerns to Health Canada.

Official Statement

Health Canada published the notice stating that ‘Stryker has identified a limited number of HeartSine samaritan PAD devices that were distributed without the required maintenance supplement.’ The agency noted that ‘this voluntary correction is being initiated to ensure all end users have access to supplemental maintenance information,’ and confirmed that the issue was identified through a customer complaint.