HeartSine Samaritan® PAD (Public Access Defibrillator) 350P/ 360P/ 450P /500P - Priority 2 - Warning

Problem or issue?  

The manufacturer has identified an issue with an internal component (the membrane tail, FA319), which could cause the device not to function. This failure could occur at any point when the device is holding a charge in preparation to deliver therapy, while delivering a shock, or after shock delivery. The device becomes inoperable after the failure occurs. The manufacturer has indicated that the likelihood of this issue occurring is low and, in most instances, the device will shock without failure.

The following additional issues currently affecting the HeartSine Samaritan PAD devices have also been identified by the manufacturer:

1. HeartSine Samaritan PAD devices were distributed without the required maintenance supplement (FA334). The manufacturer is issuing a voluntary correction to ensure all end users have access to the supplemental maintenance information.
2. In 2025, the manufacturer identified an issue related to a circuit board component that may impair the device’s ability to function (FA318). Please see FSN (HeartSine Samaritan® PAD – June 2025) and the HPRA’s previous safety notice, SN2025(3), for further information (HPRA Safety Notice – August 2025). 

What is the risk?

The component issues (FA319 and FA318) could result in a delay to treatment, or no treatment being delivered, when needed during an emergency situation. Both component issues were detected during quality testing, and to date there have been no related reports of incidents occurring during patient use. 

Why is the HPRA issuing this safety notice?

The HPRA is issuing this safety notice to ensure adequate awareness of the issue, and to highlight the need to check your AED and request a replacement, if it is in scope of one of the recall actions described above (FA319 and FA318). Stryker is recalling affected devices, however they have experienced a delay in making replacement devices available. The manufacturer recommends that devices remain in service until a replacement becomes available. 

What advice has the HPRA for users of these devices?

1. Review the list of affected devices in the FSNs and check if the device(s) in your possession is/are affected by the above field actions. Users can verify if their device serial number is affected by using the look-up tool at the following link with “AED + Pad-Pak” selected in the Product(s) dropdown:  https://heartsinerecall.com/HeartSineSamaritanPAD/LookUp
2. If you do not have access to an alternative device, the manufacturer recommends keeping your device in service until a replacement is available.
3. Complete the FSN acknowledgement form and return it to your supplier.
4. Report any safety issue to the manufacturer and to the HPRA. 

Contact Information 

Documents

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