Defibrillator manufacturer Stryker has announced a Critical Product Correction for certain Pad-Paks used with the HeartSine® samaritan® PAD Automated External Defibrillators (AEDs).

This voluntary medical device recall is being issued to alert customers that specific Pad-Pak models may be affected by a bent locator pin issue. The recall applies to Pad-Paks with expiry dates between 17 April 2025 and 1 August 2029.

• Pad-Pak-03

• Pad-Pak-03J

• Pad-Pak-04

• Pad-Pak-04J

• Pad-Pak-07

Stryker has identified that the affected Pad-Paks may not function correctly due to bent locator pins or user error caused by improper insertion of the Pad-Pak.
If this occurs, the AED may fail to deliver lifesaving therapy, which could result in a delay or complete failure of treatment during an emergency.

If you are using one of the affected Pad-Pak models, please follow the steps outlined in Stryker’s official Medical Device Recall Notice:

1. Check the expiry date on your Pad-Pak.

2. Inspect the locator pins for any signs of bending or damage.

3. Ensure correct insertion of the Pad-Pak following the provided instructions.

If you identify an impacted product:

• The affected Pad-Pak must be destroyed.

• Complete a Certificate of Destruction and email it to sales@qualsafe.org.

• Stryker will provide a replacement product at no cost.