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:
ARTG number Catalogue number / Product model

156690, 228210

350BASUK10

HeartSine SAM 350P

360BASUK10

360BASUKGW

HeartSine SAM 360P

500BASUK10

HeartSine SAM 500P
Affected serial numbers

A subset of serial numbers beginning with 21, 22, 23 or 24, and are then followed by the letter B, D, E, G or H. Please check if your AED serial number is affected as detailed below.

To view the list of all serial numbers included in this recall, please visit the Stryker website - external site.

For more information on safety alerts and product notices, please visit the Therapeutic Goods Administration (TGA) alerts resource page.

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