Product notices

Customer notification

We are pleased to have PMA approval for the HeartSine samaritan PAD family of automated external defibrillators, including SAM 350P, SAM 360P, and SAM 450P.

Product discontinuations

Stryker has announced discontinued support for HeartSine samaritan AED, HeartSine samaritan PAD 300 and 300P (SAM 300, SAM 300P) “legacy” public access defibrillators in the United States.

Stryker's planned discontinuations (October 2020)

  • HeartSine samaritan AED was discontinued in 2006 and accessories have not been marketed since 2013.
  • Pad-Pak and Pediatric-Pak are not PMA approved for use with SAM 300 or SAM 300P. Therefore, while Pad-Pak and Pediatric-Pak will continue to be available for use with SAM 350P, SAM 360P, and SAM 450P devices, Pad-Pak will not be available for use with SAM 300 or SAM 300P and Pediatric-Pak will not be available for use with SAM 300P after February 3, 2022. Note this date has been extended from February 3, 2021 to February 3, 2022.

FDA event timeline

April 2019 – The FDA communicated with all AED manufacturers regarding the final order requiring premarket approval (PMA) applications for new and existing AEDs and necessary AED accessories by February 3, 2020: 

“In April 2019, the FDA sent letters to all AED manufacturers, who did not submit a premarket approval (PMA) application for their AEDs as required by the final order, reminding them they can no longer market their AED; the letters also informed the manufactures that necessary AED accessories may not be marketed after February 3, 2020, if a PMA is not filed.” *

September 2019 – In order to allow customers adequate time to transition to PMA approved AEDs, the FDA updated the deadline for marketing AED accessories to no later than February 3, 2021.

“FDA does not intend to enforce compliance with the February 3, 2020, deadline for necessary AED accessories for one year in order to allow health care facilities time to transition to FDA-approved AEDs.” *

October 2020 – Due to hardship related to the COVID-19 pandemic the FDA updated their website with a deadline extension for marketing AED accessories to no later than February 3, 2022.


Additional resources

For more information on this product discontinuation and how we are complying with the latest FDA final order, please review the following.

FDA | Automated External Defibrillator (AEDs) website     HeartSine customer letter     HeartSine FAQs

Thank you for your business and continued partnership. We are committed to providing high-quality, clinically relevant products so that you can be confident in the care you are providing to your communities.

Please contact your local Stryker sales representative or authorized distributor to discuss trade-up and flexible financing options to support you during this transition. For more information, review the additional resources above.