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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
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; 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.
Review the recall Notification letter.
Stryker is conducting a voluntary recall as we have determined that the affected Pad-Paks may be rendered inoperable due to depleted battery cells. As a result, the affected Pad-Paks could potentially fail to power on the device if needed for use. There have been no reports of adverse events or cases of patient involvement to date.
Review the recall Notification letter.
If you have any questions or concerns, please contact HeartSine Customer Support at +44 28 9093 9400, 9:00 A.M. to 5:00 P.M. (GMT), Monday – Friday or by email at RSRecall@stryker.com.