| | Class 2 Device Recall HeartSine PadPak |  |
| Date Initiated by Firm | September 18, 2025 |
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| Date Posted | October 23, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0288-2026 |
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| Recall Event ID |
97651 |
| PMA Number | P160008 |
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| Product Classification |
Automated external defibrillators (non-wearable) - Product Code MKJ
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| Product | 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 |
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| Code Information |
PAD-PAK-01, Lot: H017-002-174 and H047-002-100, UDI: 0506016712046;
PAD-PAK-02, Lot: H023-002-051, UDI: 0506016712047;
PAD-PAK-03, Lot: H017-002-173, H047-002-101, UDI: 0506016712123;
PAD-PAK-04, Lot: H023-002-050, UDI: 0506016712124;
PAD-PAK-07, Lot: H017-002-178, UDI: 0506016712448;
PAD-PAK-03J, Lot: H017-002-071 and H047-002-035, UDI: 0506016712475;
PAD-PAK-04J, Lot: H023-002-009, UDI: 0506016712476 |
| FEI Number |
3004123209
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Recalling Firm/
Manufacturer |
HeartSine Technologies Ltd
207 Airport Road West
Belfast United Kingdom
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| For Additional Information Contact |
1425-867-5497 |
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Manufacturer Reason
for Recall | Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| 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 RSRecall@stryker.com 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 heartsinesupport@stryker.com. |
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| Quantity in Commerce | 1,291,165 units |
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| 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.
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| PMA Database | PMAs with Product Code = MKJ
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