New Voluntary Recall: HeartSine® samaritan® PAD Pad-Pak-01, Pad-Pak-02, Pad-Pak-07
Please be advised, Stryker is issuing a voluntary medical device recall to alert customers with Pad-Paks that have expiry date between April 17, 2025 – August 1, 2029, of a potential bent locator pin issue, and to provide instructions to ensure the Pad-Pak is properly inserted into the SAM PAD device.
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.
Potential Risks
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.
Step A - Check the expiry date on your Pad-Pak:
The expiry date can be found on the rear of the Pad-Pak (see diagram at right or refer to section “Set up your AED” in the IFU).
• If your Pad-Pak expires between April 17, 2025 – August 1, 2029
proceed to step B below.
Step B - Check for bent locator pins:
• Place the Heartsine Samaritan PAD device face up on a table or other flat surface. Squeeze the tab on each side of the Pad-Pak as shown on the right.
• Pull to remove the Pad-Pak from the device. Once the Pad-Pak is removed from the device check the locator pins (blue arrows in Figure 1 to the right) to ensure they are straight and not bent, as shown in step 2 at the right.
• If locator pins are straight, proceed to step C below to follow Pad-Pak insertion instructions.
• If pins are bent: Remove the Pad-Pak from your device, and set it aside. Pull another Pad-Pak from your inventory, verify locator pins are straight, then proceed to Step C below, to properly insert the Pad-Pak into the device.
• If you do not have an additional Pad-Pak in your inventory, remove the device from service and proceed
Step C - Follow Pad-Pak insertion instructions:
Illustration 1: Place your HeartSine samaritan PAD device and the Pad-Pak face up on a table or other flat surface.
Illustration 2: Slide the Pad-Pak into bottom of the AED as shown until you hear the “double click” and look at both clips to ensure they are correctly engaged.
Illustration 3: Look at both clips to ensure they are correctly engaged.
Illustration 4: Correctly engaged clips will click in and sit snugly/tightly against the AED with no gap as per the green tick. Incorrectly engaged clips will not click and will have a gap as shown in the image with the red x.
Illustration 5: Push the Pad-Pak in one last time to ensure correct engagement.
PROCEED TO STEP D IF PINS ARE BENT. IF PINS ARE NOT BENT, YOU ARE NOT IMPACTED.
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.
We are initiating a voluntary field action.
The likelihood of this issue occurring is low. Since 2018, more than 1.4 million Pad-Paks have been used worldwide, with 120 complaints reported during that time. Of these, there have been 36 adverse events of which five were confirmed to be caused by bent locator pins, two devices were not returned for investigation and 29 were determined to be related to potential use error.
This is the second recall notification issued this year (2025). But, this is a new recall notice specific to HeartSine samaritan PAD Pad-Pak-01, Pad-Pak-02, and Pad-Pak-07 units with expiry dates between April 17, 2025 – August 1, 2029. It addresses a potential issue with bent locator pins or improper insertion, which could prevent the AED from powering on or delivering a shock. Even if you’ve seen past advisories, you should carefully review this notice and follow the steps outlined.
Check the expiry date on your Pad-Pak. If it expires between April 17, 2025 – August 1, 2029, it is part of this recall.
Inspect the locator pins on the Pad-Pak. If they are straight, reinsert the Pad-Pak correctly until you hear a “click” and confirm it sits snugly with no gap.
If the pins are bent, remove that Pad-Pak from service and use a backup if available. If no spare Pad-Pak is on hand, take the AED out of service until a replacement is provided.
Complete and submit the recall form to support@aedrecall.ca so Stryker can process your replacement.
Once you complete and submit the recall response form to support@aedrecall.ca, Stryker will review your information and contact you with the next steps. If your Pad-Pak is confirmed to be affected, Stryker will provide a replacement at no cost. The timing of delivery may vary, but replacements are being processed as responses are received.
No, replacement AEDs are not being provided as part of this recall. If your AED is out of service because of a bent locator pin and you do not have a spare Pad-Pak available, you should temporarily remove the device from service until a replacement Pad-Pak arrives. If continuous AED coverage is required, you can reach out to your AED program supplier, and they can present options to switch you out of your AED.
You may use an alternate AED if available; however, the likelihood of this issue occurring is low. If you are not comfortable using your AED with the affected Pad-Pak, you may remove the device from service until you receive your replacement. Please complete and submit the recall response form to support@aedrecall.ca so Stryker can arrange your replacement Pad-Pak. If your organization requires uninterrupted AED coverage, we recommend securing an alternate unit through your AED supplier until the replacement is received.
This recall is being managed through the replacement of affected Pad-Paks at no cost. Refunds are not being offered as part of this process. To ensure your AED remains ready for use, please check your Pad-Pak as per the instructions provided, and if affected, complete and submit the recall response form to support@aedrecall.ca so a replacement Pad-Pak can be provided.
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.