BEUDAMED
    FDA Recall Open, Classified

    HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J

    Recall: Z-0288-2026 · Initiated September 18, 2025

    Recall

    Recall Number
    Z-0288-2026
    Event Number
    97651
    Firm
    HeartSine Technologies Ltd 207 Airport Road West Belfast United Kingdom
    FEI Number
    3004123209
    Product Code
    MKJ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    September 18, 2025
    Posted
    October 23, 2025

    Description

    HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J

    Reason

    Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.

    Action

    On September 18, 2025, HeartSine (Stryker) issued a "Urgent: Medical Device Recall Notification." HeartSine is asking consignees to take the following actions: 1. To ensure the device works correctly in an emergency, follow the instructions within the customer notification. A. Check the expiry date on your Pad-Pak B. Check for bent locator pins. C. Follow Pad-Paks insertion instructions. D. Submit your response online at: heartsincerecall.com. A response is required in all instances. E. Maintain Awareness F. If you have further distributed affected product(s), please forward a copy of this notice to the new responsible party and email [email protected] with both the location to which the product(s) was/were further distributed to and the quantity and lot number for any Pad-Paks that have been disposed of. If you have any questions or concerns, please contact Stryker Customer Service at +1 800 787 9537, option 2, from 8:00 AM to 7:00 PM (Eastern Time), Monday Friday, or HeartSine Technologies Technical Support at [email protected].

    Distribution

    US Nationwide distribution. Worldwide distribution to Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.

    Quantity

    1,291,165 units