Critical Product Correction Notice
HeartSine Samaritan PAD Pad-Pak
22 September, 2025
Stryker has initiated a Critical Product Correction for the HeartSine Pad-Pak (battery and electrode pack) used in HeartSine samaritan PADs (HeartSine AED).
This applies to Pad-Paks with expiry dates between 17 April 2025 – 01 August 2029. Customers are being asked to check for bent locator pins and to confirm the Pad-Pak is correctly inserted into the AED.
Issue
Some Pad-Paks may:
- Not be correctly inserted into the AED, or
- Have bent locator pins
This could result in:
- Device not powering on
- Device repeatedly prompting “apply pads to patient’s bare chest”
- Failure to deliver therapy in an emergency
Background
- The HeartSine Pad-Pak is a combined battery + electrode cartridge.
- Since 2018, 36 global events have been reported (5 confirmed bent pins, others linked to user error).
Action for Customers
- Inspect all Pad-Paks within the affected expiry range.
- Check for bent locator pins and confirm correct insertion.
Action for Sales Team
- Reassure customers this is a precautionary correction.
- Direct customers to the official Stryker communication to determine if their device is effected and() for detailed instructions. View Lookup Form HERE.
- Escalate any issues or confirmed faulty units to:
- padpak.ssp@stryker.com
- Stryker Post Market Team: +61 2 8413 1250
For more information on safety alerts and product notices, please visit the Therapeutic Goods Administration (TGA) alerts resource page.