HeartSine Samaritan® PAD Pad-Pak and Pediatric-Pak Priority 2 – Warning

27/11/2025
Medical devices HPRA safety notice

Point of Information Details 
Device Manufacturer/Supplier InformationHeartsine Technologies, Ltd. (Stryker Medical)
Target Audience Owners/ users of these devices/ Community first responders/ AED managers
What devices are affected?

HeartSine Samaritan PAD Pad-Pak 03, -03J, -04, -04J & -07

These devices are accessories to the HeartSine Samaritan PAD device. They contain the battery to power the AED, and two electrode pads to provide the electrical connection to the patient’s chest for delivery of defibrillation shock. 

Problem or issue? 

The manufacturer has identified two potential issues whereby the Pad-Pak may not be properly inserted into the AED. This can occur due to use error or due to bent locator pins in the Pad-Pak, caused during the manufacturing process. Should the issue occur, the AED may fail to power on.

What is the risk?


If the Pad-Pak is not properly inserted into the device, or if the locator pins are bent, the device may not work in an emergency.

Why is the HPRA issuing the safety notice?


The HPRA is issuing this Safety Notice to highlight the two issues of potential use error and/or bent pins associated with HeartSine Samaritan PAD Pad-Paks. 

Users are instructed to check their devices. If you find bent locator pins in your device, contact the manufacturer for a replacement. 

Check also to ensure the Pad-Pak is correctly inserted into the AED and follow the instructions provided by the manufacturer.


What advice has the HPRA for the users of these devices? 


  1. Check if your devices are affected by the bent locator pins issue. If your Pad-Pak expires between April 17, 2025 – August 1, 2029, it may have bent pins. 
  2. Follow instructions outlined in the manufacturer's field safety notice (FSN) to ensure your Pad-Pak is correctly inserted
  3. Complete the reply form in the attached FSN and return it to your supplier.
  4. Report any safety issue to the manufacturer and to the HPRA.

 

Contact Information  

 Manufacturer Authorised RepresentativeDistributor
Name Heartsine Technologies Ltd.Stryker European Operations Limited AnngroveHeartsafety Solutions
Address

207 Airport Road West,

Belfast,

BT3 9LF

IDA Business & Technology Park Carrigtwohill

Cork

T45 HX08

 

D3 Airton Business Park, Airton Road,

Dublin,

D24 PX72

Email

heartsinesupport@stryker.com

emea.pfa.hold@stryker.com 

ear.ie@stryker.com safety@hearts.ie
Telephone+44 28 9093 9400N/A01 464 4102
Websitehttps://www.stryker.com/us/en/emergency-care/product-notices/heartsine/index.htmlN/Awww.hearts.ie

HPRA Contact Information 

All safety issues relating to medical devices should be reported to the HPRA using any of the following reporting options:

Further information on the role of the HPRA in relation to medical devices is available on the regulation of medical devices section of the HPRA website.

 

Any enquiries regarding this safety notice or any medical device safety issue should be emailed to us using our Online contact form. 

 

Documents

Samaritan®PAD Pad-Pak and Pediatric-Pak_Priority2_Warning_HPRA Safety Notice PDF : 157KB | 26/11/2025 Samaritan PAD Pad-Pak and Pediatric-Pak_Heartsine_FSN for users PDF : 960KB | 27/11/2025

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