HeartSine Samaritan® PAD (Public Access Defibrillator) 350P 360P 450P 500P - Priority 2 - Warning
15/08/2025
Medical devices
HPRA safety notice
| Point of Information | Details |
| Device Manufacturer/Supplier Information | Heartsine Technologies, Ltd. (Stryker Medical) |
| Target Audience | Owners/ users of these devices/ Community first responders/ AED managers |
| What devices are affected? | Heartsine Samaritan PAD SAM 350P/SAM 360P/SAM 450P/SAM 500P |
Problem or issue?
The manufacturer has identified that an issue related to a circuit board component may impair the device’s ability to function. The failure can occur at any point, when the device is preparing 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 deliver two shocks without failure.
What is the risk?
This issue could result in a delay in treatment, or no treatment being delivered during use. The issue was detected during quality testing, and to date there have been no 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 the action.
Although the manufacturer is recalling the affected devices, it is important to note that replacements will not be available until production resumes in Q4 2025. The manufacturer recommends that devices remain in service until the replacement is available.
What advice has the HPRA for users of these devices?
- Review the list of affected devices in the FSN and check if the device(s) in your possession is/are affected by this issue. Users can verify if their device serial number is affected by using the look-up tool at the following link: HeartSine recall — June 2025 | Stryker
- If you do not have access to an alternative device, the manufacturer recommends keeping your device in service until a replacement is available.
- Complete the reply form in the attached FSN and return it to your supplier.
- Report any safety issue to the manufacturer and to the HPRA.
Contact Information
| Manufacturer | Authorised Representative | Distributor | |
| Name | Heartsine Technologies Ltd. | Keane, Louise | Heartsafety Solutions |
| Address | 207 Airport Road West | IDA Business & Technology Park Carrigtwohill Postcode: T45 HX08 City: Cork | D3 Airton Business Park, Airton Road, Dublin, D24 PX72 |
| ear.ie@stryker.com | |||
| Telephone | +44 28 9093 9400 | N/A | 01 464 4102 |
| Website | https://www.stryker.com/us/en/emergency-care/product-notices/heartsine/index.html | N/A | www.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:
- Telephone: +353-1-6764971
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
Opens in new window Samaritan PAD public access defibrillator_Heartsine_FSN for users PDF : 287KB | 15/08/2025 Opens in new window Samaritan PAD public access defibrillator_ Priority2_Warning_HPRA Safety Notice PDF : 153KB | 15/08/2025Product images
