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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.
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.
Review the recall Notification letter.
Product issue:
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.
Recall Number: PR2922086
How to proceed:
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.