Heartsine Samaritan AED Defibrillator Recall | Everything You Need To Know

Heartsine Samaritan PAD AED Recall June 2025

Overview

In June 2025, Stryker Australia, on behalf of HeartSine Technologies, initiated an urgent recall (market action) affecting a subset of HeartSine Samaritan Public Access Defibrillators (PADs) supplied in Australia.

The recall was notified and overseen by the Therapeutic Goods Administration (TGA) and applies nationwide.

The recall relates to a manufacturing issue identified during internal quality testing that may affect device functionality. No patient harm has been reported in Australia at the time of notification.

Affected Devices

The recall applies to specific serial numbers only for the following HeartSine Samaritan PAD models listed on the Australian Register of Therapeutic Goods (ARTG):

  1. HeartSine SAM PAD 350P
  2. HeartSine SAM PAD 360P
  3. HeartSine SAM PAD 500P

Check Affected Serial Numbers

  1. Affected devices generally have serial numbers beginning with 21, 22, 23, or 24
  2. Certain letter designators apply (e.g. B, D, E, G, H)
  3. Not all devices within these ranges are affected

Device owners must confirm impacted devices using the manufacturer’s serial‑number verification process.

Notes
Device serial numbers can be checked online here 

Reason for the Recall

The recall was initiated after identification of a manufacturing issue involving a circuit board component used in certain production lots.

This issue may cause the AED to:

  1. Fail while holding a charge
  2. Fail during preparation to deliver therapy
  3. Fail during shock delivery
  4. Become inoperable after a shock has been delivered

The issue was identified during internal testing, not through patient use or field incidents.

Patient Safety Risk

If the defect occurs during an emergency, the AED may:

  1. Fail to deliver a shock, or
  2. Cause a delay in treatment during sudden cardiac arrest

Due to the time‑critical nature of defibrillation, this represents a potentially serious clinical risk.

However:

  1. No injuries, deaths, or adverse events have been reported in Australia
  2. The risk assessment is based on theoretical failure scenarios

Guidance During the Recall

In consultation with the TGA, Stryker Australia advised that affected AEDs should generally remain in service unless an alternative defibrillator is available.

Key Guidance

  1. Do not remove the AED from service if it is the only defibrillator available
  2. Continue routine visual and status indicator checks
  3. Follow existing inspection and readiness procedures
  4. Arrange replacement as directed by the manufacturer

This approach reflects a risk‑based assessment that having an AED available is safer than having no AED at all.

Corrective Actions

As part of the recall, Stryker Australia committed to:

  1. Identifying affected devices by serial number
  2. Notifying customers with impacted AEDs
  3. Implementing manufacturing process corrections
  4. Providing replacement AEDs to affected customers

Customers are required to:

  1. Register affected devices with the manufacturer
  2. Maintain records of serial numbers
  3. Await replacement coordination instructions

Regulatory Oversight and Reporting

The recall remains an active market action under TGA oversight until all corrective actions are completed.

Users are encouraged to:

  1. Report any suspected device malfunctions or adverse events
  2. Use the TGA Incident Reporting and Investigation Scheme (IRIS) for reporting

Summary

The June 2025 HeartSine samaritan AED recall in Australia is a precautionary, regulator‑supervised response to a manufacturing defect identified during internal testing. While the potential consequences of failure are serious, no patient harm has been reported, and guidance emphasises maintaining AED availability while replacements are arranged.