Recall MonitorHealth ProductsType I recall
HeartSine® Pad-Pak™
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: HeartSine® Pad-Pak™
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type I
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| HeartSine® Pad-Pak™ | More than 10 numbers, contact manufacturer. | PAD-PAK-01 |
| HeartSine® Pediatric-Pak™ | More than 10 numbers, contact manufacturer. | PAD-PAK-02 |
| HeartSine® Pad-Pak-07 Battery & Defibrillation Pads | More than 10 numbers, contact manufacturer. | PAD-PAK-07 |
Issue
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