Home / Brands / HeartSine Technologies
HeartSine Technologies Recalls
8 recalls on record · November 7, 2012 to October 29, 2025 · Medical Devices
Recalls by year
12
14
23
24
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 29, 2025Medical DevicesFDA
HeartSine Technologies Ltd recalls 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
Hazard: Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
August 6, 2025Medical DevicesFDA
HeartSine Technologies Ltd recalls HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibr
Hazard: Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
May 22, 2024Medical DevicesFDA
HeartSine Technologies Ltd recalls HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
Hazard: Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual instructional icons will still be present, but this issue could potentially lead to no therapy or a delay in therapy.
February 21, 2024Medical DevicesFDA
HeartSine Technologies Ltd recalls HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-
Hazard: Automated external defibrillators were shipped in their test configuration so there is a potential to have incorrect language, and CPR duration resulting in the device prompting users to perform CPR for 5-seconds, and it could analyze heart rhythm and instruct users to deliver a shock every 5-seconds if a shockable heart rhythm is detected, potentially leading to no therapy or delayed therapy.
July 19, 2023Medical DevicesFDA
HeartSine Technologies Ltd recalls HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public
Hazard: 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.
March 15, 2023Medical DevicesFDA
HeartSine Technologies Ltd recalls Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-
Hazard: Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.
July 30, 2014Medical DevicesFDA
Heartsine Technologies, Limited recalls Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated
Hazard: A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy.
November 7, 2012Medical DevicesFDA
Heartsine Technologies, Limited recalls HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C
Hazard: Certain Samaritan 300/300P PAD devices may experience one or both of the following conditions that could affect the ability to deliver therapy to a patient in an SCA event if needed: Issue 1 (On/Off Issue): the device may turn itself on and off without input from the user. When this occures, the normal sequence of audible instruction prompts that occurs when the device is turned on will be emit