Voluntary Recall: HeartSine® samaritan® PAD SAM 350P/360P/500P
This device recall notification is being issued to alert customers with HeartSine samaritan PAD SAM 350P, 360P, and 500P devices of a potential device malfunction issue. Out of an abundance of caution, Stryker is completing a voluntary recall of these devices.
NOTE: If you have serial numbers affected by the voluntary recall, you MUST submit the form below or you will receive additional follow-up from our team.
It was determined during extensive quality testing that a manufacturing process issue related to a circuit board component may impair the device’s ability to function or cause failure. 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.
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, not during patient use. There have been no adverse events reported related to this product issue.
A manufacturing process change that was implemented to achieve compliance with European environmental regulatory requirements has impacted the quality of a component of the device’s electrical circuit, causing devices to experience failure during extensive quality testing.
We are initiating a voluntary field action.
The likelihood of this issue occurring is low. This issue was identified through quality testing and not through patient use. There have been no adverse events reported related to this product issue.
This is the first notification issued by Stryker regarding this component issue. This issue was identified due to a change in a manufacturing process change that was implemented to achieve compliance with European environmental regulatory requirements.
We recommend that customers keep their devices in service until replacement devices are available.
Alternate devices are not being offered at this time as the affected devices can be kept in use until a HeartSine replacement is available. The benefits of attempting to use an AED during sudden cardiac arrest are greater than the risk of not having one to use or not attempting to use one in an emergency.
Stryker is working on implementing updates for the HeartSine devices and currently anticipates returning to production in Q4 2025. There are regional regulatory requirements that may add additional time to availability. Once shipping of products resumes, we anticipate it could take several months to complete all the impacted product replacements in your region.
You may use an alternate AED if available; however, the likelihood of this issue occurring is low. This issue was identified through quality testing and not through patient use. There have been no adverse events reported related to this product issue. If this issue occurs during patient use, please continue CPR and seek an alternative device.We recommend that customers keep their devices in service until replacement devices are available.
The probability of the issue occurring is low. Based on the testing data analysis, completed in March 2025, there is a 99.98% likelihood of a successful delivery of at least one shock. At this time, Stryker will be providing replacement devices when they become available. Please continue to keep the device in service in the meantime. Stryker does not intend to provide a refund at this time since we will be providing replacement devices as soon as they are available.
Stryker is working on implementing updates for the HeartSine devices and currently anticipates returning to production in Q4 2025. There are regional regulatory requirements that may add additional time to availability.
Once shipping of products resumes, we anticipate it could take several months to complete all the impacted product replacements in your region.
Please reach out to Rescue7 directly by calling 1-888-878-5094 or emailing support@aedrecall.ca and our AED Recall Team will be more than happy to assist you in this matter.
We thank you sincerely for your help and support in submitting your response by September 28th, 2025. We regret any inconvenience that may be caused and would like to reassure you that we are committed to meeting our high internal quality standards and your expectations. Please feel free to contact us at 1-888-878-5094
Health Canada has been notified of this recall by Stryker. Adverse reactions or quality problems experienced with the use of this product may be reported to Health Canada through the Canada Vigilance Program, either online, by mail, or by fax.