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Heartsine® pad-pak™

Official notice

11 Sept 2025

HighHealth Canada

An official Health Canada notice concerns Heartsine® pad-pak™. Post-market surveillance has revealed that the Pad-Paks are not always inserted properly into the HeartSine Samaritan® PAD devices as outlined in the instructions for use (IFU), which can create failure during device use. Upon investigation, the potential causes of the improper insertion of Pad-Paks include use error and bent locator pins, which may occur during the manufacturing process. In the event the device is unable to complete connection, the device will repeatedly prompt "apply pads to patient's bare chest". In some cases, the AED device may fail to power on entirely. Recall start date: August 22, 2025 Published 2025-09-11.

What to do now

Contact the manufacturer if you require additional information.

Recall number

78056

Official notice

2025-09-11

The hazard

Post-market surveillance has revealed that the Pad-Paks are not always inserted properly into the HeartSine Samaritan® PAD devices as outlined in the instructions for use (IFU), which can create failure during device use. Upon investigation, the potential causes of the improper insertion of Pad-Paks include use error and bent locator pins, which may occur during the manufacturing process. In the event the device is unable to complete connection, the device will repeatedly prompt "apply pads to patient's bare chest". In some cases, the AED device may fail to power on entirely. Recall start date: August 22, 2025

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

78056

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Affected products

Product 1

Affected products - HeartSine® Pad-Pak™, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - PAD-PAK-01

Product 2

Affected products - HeartSine® Pediatric-Pak™, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - PAD-PAK-02

Product 3

Affected products - HeartSine® Pad-Pak-07 Battery & Defibrillation Pads, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - PAD-PAK-07

Risk / hazard

Post-market surveillance has revealed that the Pad-Paks are not always inserted properly into the HeartSine Samaritan® PAD devices as outlined in the instructions for use (IFU), which can create failure during device use. Upon investigation, the potential causes of the improper insertion of Pad-Paks include use error and bent locator pins, which may occur during the manufacturing process. In the event the device is unable to complete connection, the device will repeatedly prompt "apply pads to patient's bare chest". In some cases, the AED device may fail to power on entirely. Recall start date: August 22, 2025

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Heartsine, Heartsine® Pad-pak™.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

high

Recall details

Recall number

78056

Classification

Type I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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