CLASS II ONGOING Device recall · Reported 19 Jul 2023 · FDA Enforcement Report

HeartSine, REF: Pad-pak-01, Pad-pak-03 AND Pad-pak-03j, CE0123 sold recalled

HeartSine Technologies is recalling HeartSine, REF: Pad-pak-01, Pad-pak-03 AND Pad-pak-03j, CE0123 sold, distributed nationwide in the US. The recall was initiated on 26 Apr 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel #/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

Quantity recalled30,022 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2143-2023
FDA event ID: 92346
Recalling firm: HeartSine Technologies, Belfast, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 26 Apr 2023
FDA classified: 13 Jul 2023
Reported: 19 Jul 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Pacemakers & Defibrillators

Timeline

26 Apr 2023	Recall initiated by company
13 Jul 2023	Classified by FDA	+78 days
19 Jul 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Alaska Alabama Arkansas Arizona California Connecticut Florida Georgia Hawaii Iowa Illinois Indiana Kansas Kentucky Massachusetts Maryland Maine Michigan Minnesota Missouri

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from HeartSine Technologies

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Reported	Class	Recall	Company	Reason	Where
29 Oct 2025Device	CLASS II	HeartSine Pad-Pak recalled by HeartSine Technologies	HeartSine Technologies	Other	Nationwide
22 May 2024Device	CLASS II	HeartSine samaritan PAD (Public Access Defibrillator), Type recalled	HeartSine Technologies	Other	Nationwide
21 Feb 2024Device	CLASS II	HeartSine samaritan PAD (Public Access Defibrillator): Type recalled	HeartSine Technologies	Other	Nationwide
15 Mar 2023Device	CLASS II	Heartsine Samaritan PAD: SAM 350P semi-automatic recalled	HeartSine Technologies	Other	8 states
30 Jul 2014Device	CLASS II	Pad-Pak and Pedi-Pak accessories recalled by Heartsine Technologies	Heartsine Technologies	Packaging Defects	Nationwide

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