HeartSine recall – June 2025

Product description:

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

Product affected:

Affected devices include a subset of HeartSine samaritan PAD Models; 350P, 360P, 450P and 500P. 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.

Product issue:

It was determined during internal quality testing that a manufacturing process issue related to a circuit board component may impair the device’s ability to function or cause failure.

Potential risks:

If this issue occurs, the device may fail to deliver the intended therapy during use, potentially leading to a delay in treatment or no treatment being delivered during use.

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

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 issue.

How to check if your product is affected:

To check if your product is affected, go to: FA318-T3 Recall | Stryker