Updated HeartSine Field Action - July 2026

Product description:

The HeartSine® samaritan® Public Access Defibrillator (PAD) is a small, lightweight, portable, battery operated Automated External Defibrillator (AED) designed to treat victims of cardiac arrest.

Product affected:

To find your AED model and serial number, see the labels on the rear of your AED as shown below:

Product problem (June 2025)

A manufacturing process problem related to a circuit board component may impair the device’s ability to function or cause failure.

New problems identified (updated July 2026):

• The membrane tail, an internal component, may develop an intermittent fault that could render the device inoperable.
• Devices were distributed without supplementary maintenance instructions.
  

Potential risks:

If this problem occurs, the device may fail to deliver the intended therapy during use, potentially leading to a delay in treatment or no treatment being delivered. These problems were observed during non-standard rework process and quality testing, not during patient use.

The omission of this supplement may result in users not performing the recommended quarterly power-cycle check. If the check is not performed, the device may have an undetected audio-prompt failure that could result in reduced device readiness and user confusion.

There have been no adverse events reported related to these problems.

What should I do:

Until a replacement is available, Stryker recommends keeping your HeartSine® samaritan® PAD in service if you do not have an alternative public access defibrillator. This recommendation is based on internal testing demonstrating a low probability of failure due to this product manufacturing problem.

Check whether your device is affected and complete the online acknowledgement form via the HeartSine Product Notice website. You will also be asked to provide shipping details for replacement product: https://www.stryker.com/us/en/emergency-care/product-notices/heartsine/index.html

For devices affected by the maintenance supplement problem, download a copy of the maintenance supplement when completing the acknowledgement process. Store the supplement with the device user manual/user handbook and AED, and perform the additional maintenance check every three months until a replacement copy is received.

Once your registration has been verified, you will be added to the list to receive a replacement AED.

Stryker has experienced a delay in the availability of replacement devices. For customers with affected products who have completed the online acknowledgement form, replacement units are currently being allocated and shipped. All replacement units are expected to be supplied by 31 May 2027.

If you have any questions, please contact our dedicated HeartSine Recall Support team on +1800 738 521.