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The HeartSine samaritan PAD is a small, lightweight, portable, battery operated Automated External Defibrillator (AED) designed to treat victims of cardiac arrest.
This device recall notification is being issued to alert customers with HeartSine samaritan PAD SAM 350P/SAM 360P/SAM 450P/SAM 500P devices of a missing maintenance supplement. Out of an abundance of caution, Stryker is completing a voluntary correction of these devices.
Affected devices were received by customers within March 11, 2024 – February 18, 2025.
Stryker has identified that a limited number of HeartSine samaritan PAD devices were distributed without the required maintenance supplement. This supplement contains periodic maintenance instructions implemented as an additional risk-control measure. While most devices contain the maintenance supplement, this voluntary correction is being initiated to ensure all end users have access to supplemental maintenance information. This issue was identified through a customer complaint.
Omission of this supplement may result in users not performing the recommended quarterly power-cycle check. If the check is not performed, the device may have an undetected audio-prompt failure that could result in reduced device readiness and user confusion. This issue was identified through a customer complaint.
There have been no adverse events reported related to this device recall notification.
Download a copy of the missing maintenance supplement when acknowledging the recall at https://www.stryker.com/us/en/emergency-care/product-notices/heartsine/index.html.
Maintain awareness of this communication internally and near the affected unit until all required actions have been completed within your facility and the unit has been replaced.
The HeartSine samaritan PAD is a small, lightweight, portable, battery operated Automated External Defibrillator (AED) designed to treat victims of cardiac arrest.
This device recall notification is being issued to alert customers with HeartSine samaritan PAD SAM 350P/SAM 360P/SAM 450P/SAM 500P devices of a potential device malfunction. Out of an abundance of caution, Stryker is completing a voluntary recall/removal of these devices.
Stryker has recently identified an issue with the membrane tail, an internal component, which 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.
Due to the internal component issue, 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. This issue was observed during non-standard rework process and quality testing, not during patient use.
There have been no adverse events reported related to this device recall notification.
Acknowlege the recall at https://www.stryker.com/us/en/emergency-care/product-notices/heartsine/index.html.
Maintain awareness of this communication internally and near the affected unit until all required actions have been completed within your facility and the unit has been replaced.
If your device experiences the above issue during use, please seek an alternative defibrillator and contact your Authorized Distributor or HeartSine Technologies Technical Support at heartsinesupport@stryker.com.
Until a replacement is available, Stryker recommends keeping your HeartSine samaritan PAD in service if you do not have an alternative public access defibrillator. This recommendation is based on internal testing demonstrating a low probability of failure due to these product manufacturing issues.
Both the Adult and Pediatric Pad-Pak accessories to the HeartSine samaritan PAD device 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.
HeartSine samaritan® PAD Pad-Pak-03, -03J, -04, -04J & -07.
Post-market surveillance has revealed that the Pad-Paks are not always inserted properly into the HeartSine samaritan PAD devices as outlined in the IFU, which can create failure during device use. In the event the device is unable to complete connection, the device will repeatedly prompt “Apply Pads to patient’s bare chest”. In some cases, the AED device may fail to power on entirely.
Upon investigation, two potential causes of the improper insertion of Pad-Paks include use error and bent locator pins, which may occur during the manufacturing process.
The connection issues that may arise from improper insertion of the Pad-Pak are not always obvious to the user when the Pad-Pak is inserted into the HeartSine samaritan PAD device. If the Pad-Pak is not properly inserted into the HeartSine samaritan PAD device, or if the Pad-Pak locator pins are bent, 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. A delay in treatment or no treatment may result in serious injury or patient expiry.
To check if your product is affected, go to: HeartSine recall — October 2025 | Stryker
The HeartSine samaritan PAD is a small, lightweight, portable, battery operated Automated External Defibrillator (AED) designed to treat victims of cardiac arrest.
Affected devices include a subset of HeartSine samaritan PAD Models; 350P, 360P, 450P and 500P. A subset of serial numbers beginning with 21, 22, 23 or 24, and are then followed by the letter B, D, E, G or H. Please check if your AED serial number is affected as detailed below.
It was determined during internal quality testing that a manufacturing process issue related to a circuit board component may impair the device’s ability to function or cause failure.
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 and the issue was not observed during patient use. There have been no adverse events reported related to this issue.
Until a replacement is available, Stryker recommends keeping your HeartSine samaritan PAD in service if you do not have an alternative public access defibrillator. This recommendation is based on internal testing demonstrating a low probability of failure due to this product manufacturing issue.
To check if your product is affected, go to: HeartSine recall — June 2025 | Stryker
The HeartSine samaritan PAD is a small, lightweight, portable, battery operated Automated External Defibrillator (AED) designed to treat victims of cardiac arrest.
Affected devices include a subset of HeartSine samaritan PAD Models; 300P, 350P, 360P, 450P and 500P. A subset of serial numbers beginning with 16, 17, 18, 19, 20, 21, 22, 23 or 24, and are then followed by the letter B, C, D, E, G or H. Please check if your AED serial number is affected as detailed below.
We have determined that a manufacturing related issue may impair device audio prompts.
If this issue occurs, the device will fail to deliver voice prompts potentially leading to a delay or no treatment being delivered during use.
This issue was observed during quality testing and observed during patient use. There has been one adverse event relating to this issue in which the device failed to deliver voice prompts.
Stryker recommends the following tests to ensure that your HeartSine samaritan PAD will deliver voice prompts: Instructions.