HeartSine Technologies recalled 1,291,165 Pad-Pak defibrillator pads sold nationwide in the United States and worldwide. A defect may allow damage pins to disrupt the mechanical fit and electrical contact. Stop using the pads immediately and follow the manufacturer's recall instructions.
Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact HeartSine Technologies Ltd or your healthcare provider for instructions. Notification method: Letter
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Pad-Pak defibrillator pads are electrode pads used with HeartSine Samaritan PAD devices to deliver external defibrillation in emergencies.
Damaged pins can impair the pad’s fit and electrical contact, reducing the effectiveness of defibrillation.
This recall is not part of a broader industry pattern.
No injuries have been reported yet. Immediate discontinuation of use is required to avoid potential device failure during emergencies.
Refer to the FDA recall page and manufacturer guidance for exact identification details
Remedies such as replacement pads or refunds are typically processed within weeks to months depending on manufacturer programs
Keep the recall notice, model numbers, lots, UDIs, correspondence with the manufacturer, and any receipts or proof of purchase
Model numbers: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J. Sold in the United States nationwide and distributed worldwide to countries including 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, Qatar
No injuries or incidents have been reported.
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