Data / Medical devices / United Kingdom / Heartsine Technologies, Ltd
Heartsine Technologies, Ltd: FDA-registered device maker in BELFAST Northern Ireland, United Kingdom, 1 PMA approval
Heartsine Technologies, Ltd is registered with the FDA (registration 3004123209) in BELFAST Northern Ireland, United Kingdom. It lists 3 device types. The FDA files 1 PMA approval under its listings, the newest dated January 12, 2017. 10 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004123209
- Address
- 207 Airport Road West, BELFAST Northern Ireland, United Kingdom, BT3 9ED
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Manufacturer, Specification developer
- First device listed
- July 29, 2013
- Registered through
- 2026
- Brand names listed
- Digital Port Connector, HeartSine Gateway, HeartSine samaritan PAD 350P (SAM 350P), HeartSine samaritan PAD 360P (SAM 360P), HeartSine samaritan PAD 450P (SAM 450P), Pad-Pak-01, Pad-Pak-02, Pad-Pak-07 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated External Defibrillators (Non-Wearable) | MKJ | 3 | Manufacturer, Specification developer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Over-The-Counter Automated External Defibrillator | NSA | 3 | Manufacturer, Specification developer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| January 12, 2017 | P160008 | HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) | MKJ | 32 | June 22, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 27, 2026 | 99568 | Class II | Ongoing | HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device, US English with Gateway - 2 Min | Due to a damaged (over stretched) membrane tail that causes an intermittent fault. | accessdata.fda.gov |
| July 27, 2026 | 98483 | Class III | Ongoing | HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016 | Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check. | accessdata.fda.gov |
| September 18, 2025 | 97651 | Class II | Ongoing | 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 | Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact. | accessdata.fda.gov |
| June 30, 2025 | 96890 | Class II | Ongoing | HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan PAD (Public Access Defibrillator) | Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks) | accessdata.fda.gov |
| April 8, 2024 | 94076 | Class II | Ongoing | HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P | 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. | accessdata.fda.gov |
| February 14, 2024 | 93962 | Class II | Ongoing | HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM 360P/360-STR-JA-10, 360-STR-DE-10, 360-STR-UK-10; SAM 450P/450-UNIT-US-08,; SAM 500P/500-BAS | 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 leadi | accessdata.fda.gov |
| April 26, 2023 | 92346 | Class II | Ongoing | 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 | 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. | accessdata.fda.gov |
| February 1, 2023 | 91659 | Class II | Ongoing | Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor | Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy. | accessdata.fda.gov |
| June 12, 2014 | 68703 | Class II | Terminated | Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the Heart | A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy. | accessdata.fda.gov |
| September 13, 2012 | 63139 | Class I | Terminated | HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Product Usage: Samaritan 300/300P PAD is indicated for use on victims of sud | 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 | accessdata.fda.gov |
Compare with other makers
- All makers of Over-The-Counter Automated External Defibrillator
- All makers of Automated External Defibrillators (Non-Wearable)
- All makers of Medical Device Data System
Updated September 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.