Defibrillator Pad Recall: HeartSine Pad-Pak
Announced 2025-10-29 · FDA
HeartSine Technologies Ltd is recalling its Pad-Pak defibrillator pads because the pads may contain damage pins that disrupt the mechanical fit and electrical contact. The recall covers multiple Pad-Pak variants (PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J) with specific lots and UDIs; about 1,291,165 units were distributed in the US and worldwide.
| Brand | HeartSine Technologies Ltd |
|---|---|
| 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 |
| Reason | Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact. |
| Severity | moderate |
| Units affected | 1291165 |
| 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. |
| Agency | FDA |
| Recall / campaign no. | 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 |
WHAT YOU SHOULD DO
- Do not use the affected Pad-Pak pads with any HeartSine AED unless instructed otherwise.
- Check if your Pad-Pak batch/lot matches recall details (PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J) and the associated Lot/UDI numbers.
- Contact HeartSine or the AED distributor/provider for replacement or return instructions.
- If you are unsure whether your pads are affected, contact the manufacturer or your device supplier for confirmation before use.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.