Health product recall

HeartSine® Samaritan® Pads

Last updated

Summary

Product
HeartSine® Samaritan® Pads
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Industry

Affected products

Affected products

Lot or serial number

Model or catalog number

HeartSine® Samaritan® Pad 360P

More than 10 numbers, contact manufacturer.

360-BAS-CN-10

HeartSine® Samaritan® Pad 360P

More than 10 numbers, contact manufacturer.

360-BAS-CF-10

HeartSine® Samaritan® Pad 360P

More than 10 numbers, contact manufacturer.

360-STR-CF-10

HeartSine® Samaritan® Pad 360P

More than 10 numbers, contact manufacturer.

360-STR-CN-10

HeartSine® Samaritan® Pad 360P

More than 10 numbers, contact manufacturer.

360-TSO-CN-10

HeartSine® Samaritan® Pad 350P

More than 10 numbers, contact manufacturer.

350-TSO-CN-10

HeartSine® Samaritan® Pad 350P

More than 10 numbers, contact manufacturer.

350-BAS-CN-10

HeartSine® Samaritan® Pad 350P

More than 10 numbers, contact manufacturer.

350-BAS-CF-10

HeartSine® Samaritan® Pad 350P

More than 10 numbers, contact manufacturer.

350-STR-CN-10

HeartSine® Samaritan® Pad 500P

More than 10 numbers, contact manufacturer.

500-STR-CF-10

HeartSine® Samaritan® Pad 500P

More than 10 numbers, contact manufacturer.

500-STR-CN-10

HeartSine® Samaritan® Pad 500P

More than 10 numbers, contact manufacturer.

500-BAS-CN-10

HeartSine® Samaritan® Pad 500P

More than 10 numbers, contact manufacturer.

500-BAS-CF-10

Issue

It was determined during rigorous quality testing that a manufacturing process-related issue may impair the device's ability to function or cause failure. The likelihood of this occurring is 0.0128% (low/remote).

Recall start date: May 14, 2025

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Heartsine Technologies, Ltd.

207 Airport Road West, Belfast, Northern Ireland, United Kingdom, BT3 9ED

Published by
Health Canada
Audience
Industry
Recall class
Type II
Identification number
RA-77621

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