HeartSine recall - June 2025

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

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

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. The problem was observed during quality testing and not during patient use. There have been no adverse events reported related to this problem.

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 and register impacted devices via the website link and provide shipping details for replacement product: https://heartsinerecall.com/HeartSineSamaritanPAD/LookUp

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

Stryker has experienced delays in the availability of replacement devices. Replacement units are currently being allocated and shipped to customers. All replacement units will be supplied by 31 May 2027.

If you have any questions, please contact our dedicated HeartSine Recall Support team on 02 9170 9131.