HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device, US English with Gateway - 2 Min CPR UDI-DI code: 0506016712804 HeartSine SAM 360P 360P US Device, US English - 2 Min CPR UDI-DI code: 0506016712068 HeartSine SAM 450P SAM 450P US Device, US English (2 min CPR) UDI-DI code: 0506016712069

Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.

On 07/28/2026, Stryker sent several versions of an Urgent: Medical device recall letter that outlines two issues: 1) An issue with the membrane tail, an internal component, could cause an intermittent fault. 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. 2) A limited number of HeartSine samaritan PAD devices were distributed without the required maintenance insert. This insert contains periodic maintenance instructions implemented as an additional risk control measure. While most devices contain the maintenance insert, this voluntary correction is being initiated to ensure all end users have access to the supplemental maintenance information. For the missing required maintenance insert (issue 2), Customers are instructed to: 1. Identify impacted devices by verifying if your device serial numbers are included in the list at the link https://heartsinerecall.com/HeartSineSamaritanPAD/LookUp. For this field action notice, select AED + Pad-Pak. 2. Download a copy of the missing maintenance insert when acknowledging the recall and store with your devices user manual until a replacement is received. For questions or concerns, contact Stryker Customer Service at +1 8007879537, option 2, from 8 AM to 7 PM Eastern Time, Monday to Friday, your Authorized Distributor, or HeartSine Technologies Technical Support at [email protected].