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
Summary
The FDA issued a Class II for HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK- by HeartSine Technologies Ltd. Reason: Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact..
Details
Source
Device Recall
External ID
Z-0288-2026
Action Date
2025-10-29
Status
Ongoing
Category
device
Product 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
Lot/Code Info: 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
Quantity Affected: 1,291,165 units
Reason for Recall
Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-18
Company
Belfast
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 308 device recalls issued in the same week, part of 403 device-related FDA actions this month.
HeartSine Technologies Ltd has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (HeartSine Technologies Ltd) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does HeartSine Technologies Ltd have FDA actions?
HeartSine Technologies Ltd has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0288-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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