HeartSine Pad-Pak (HeartSine) – Defibrillator Pin Damage (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
HeartSine Technologies Ltd 207 Airport Road West Belfast United Kingdom
Lot Codes / Batch Numbers
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
Products Sold
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
HeartSine Technologies Ltd 207 Airport Road West Belfast United Kingdom is recalling HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD due to Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026