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HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the Hea...

FDA Device Recall #Z-2143-2023 — Class II — April 26, 2023

Recall Summary

Recall Number Z-2143-2023
Classification Class II — Moderate risk
Date Initiated April 26, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm HeartSine Technologies Ltd
Location Belfast, N/A
Product Type Devices
Quantity 30,022 units

Product Description

HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P

Reason for Recall

Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which could prevent the defibrillator from analyzing patient condition or delivering therapy correctly.

Distribution Pattern

Worldwide Distribution: US (nationwide): AK, AL, AR, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA & WI and OUS (countries of): Australia, Canada, Denmark, France, Iceland, Ireland, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Peru, Poland, Singapore, South Africa, Spain, Thailand, & United Kingdom.

Lot / Code Information

Model #/UDI-DI #: 360-BAS-UK-10/05060167122606, 350-BAS-UK-10/05060167121418, 350-BAS-AS-10/05060167121371, 350-BAS-CF-10/05060167124747, 350-BAS-CN-10/05060167121593, 350-BAS-JA-08/05060167124525, 350-BAS-KO-10/05060167121517, 350-BAS-MS-10/05060167120800, 350-BAS-USROW-10/05060167121630, 360-BAS-AS-10/05060167122514, 360-BAS-CN-10/05060167125751, 360-BAS-KO-10/05060167122712, 360-BAS-SJ-10/05060167128028, 450-BAS-JA-08/05060167127663, 500-BAS-AS-10/05060167125812, 500-BAS-CF-10/05060167125836, 500-BAS-CN-10/05060167125843, 500-BAS-KO-10/05060167126444, 500-BAS-TH-10/05060167125997, 500-BAS-UK-10/05060167122453, PAD-PAK-01/05060167120466,PAD-PAK-03/05060167121234,PAD-PAK-03j/05060167124754 Models/Lot # 360-BAS-UK-10/ A3659, A3655, A3664, A3654, A3803, A3829, A3840, A3842, A3848, A3840, A3843, A3842, A3844, A3842, J0754, J0754, J0755, J0752, J0798; 350-BAS-UK-10/ A3664, A3799, A3803, A3829,A3840,A3846, J0753, J0753, J0754, J0756; 350-BAS-AS-10/ A3656; 350-BAS-CF-10/ A3635, A3805, J0801; 350-BAS-CN-10/ A3633, A3636, A3805, A3833, J0801; 350-BAS-JA-08/ A3779 A3783, A3780, A3783, J0758, J0758; 350-BAS-KO-10/ J0753; 350-BAS-MS-10/ J0753; 350-BAS-USROW-10/ A3644; 360-BAS-AS-10/ A3656; 360-BAS-CN-10/ A3635; 360-BAS-KO-10/A3660 A3646, A3665, J0753, J0754; 360-BAS-SJ-10/ A3660; 450-BAS-JA-08/ A3779, A3783, A3788, A3821; 500-BAS-AS-10/ A3656; 500-BAS-CF-10/ A3635; 500-BAS-CN-10/ A3632, A3635, A3634, A3681; 500-BAS-KO-10/ A3660; 500-BAS-TH-10/ J0754, J0755, J0754; 500-BAS-UK-10/ A3654, A3654, A3664, A3664, A3765, A3787, A3801, A3840, J0753, J0755, J0754, J0756, J0748, J0798; PAD-PAK-01/ A3632 A3633 A3634 A3635 A3636 A3637 A3642 A3656 A3657 A3657 A3657 A3662 A3669 A3681 A3678 A3682 A3766, A3777 A3778 A3781 A3782 A3805 A3807 A3833 A3833 A3834 A3834 A3832 A3840 J0759 J0761 J0760; PAD-PAK-03/ A3638 A3639 A3640 A3658 A3644 A3644 A3655 A3666 A3653 A3652 A3641 A3643 A3660 A3664 A3665 A3672 A3663 A3668 A3667 A3661 A3659 A3764 A3765 A3770 A3772 A3773 A3774 A3775 A3776 A3779 A3784 A3785 A3786 A3787 A3787 A3785 A3799 A3799 A3800 A3801 A3802 A3802 A3803 A3804 A3829 A3829 A3840 A3845 A3846 A3847 A3849 A3849 A3845 J0749 J0749 J0748 J0750 J0751 J0752 J0753 J0753 J0754 J0756 J0786 J0786 J0790 J0791 J0787 J0788 J0788 J0789 J0792 J0792 J0795 J0794 J0793 J0792 J0796 J0797 J0798 J0799; PAD-PAK-03j/ A3788 and A3821

Other Recalls from HeartSine Technologies Ltd

Recall # Classification Product Date
Z-0288-2026 Class II HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02,... Sep 18, 2025
Z-2174-2025 Class II HeartSine SAM 350P, HeartSine SAM 360P, and Hea... Jun 30, 2025
Z-1820-2024 Class II HeartSine samaritan PAD (Public Access Defibril... Apr 8, 2024
Z-1141-2024 Class II HeartSine samaritan PAD (Public Access Defibril... Feb 14, 2024
Z-1217-2023 Class II Heartsine Samaritan PAD: SAM 350P semi-automati... Feb 1, 2023

Frequently Asked Questions

Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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