FDA-Device2026-10-07Class IIIMISBRANDING
HeartSine samaritan PAD defibrillators recalled for missing maintenance instructions
What this means
HeartSine distributed certain models of samaritan PAD defibrillators without a required Maintenance Supplement document. This document provides instructions for an additional quarterly (every 3 months) maintenance check beyond the standard monthly check. Without these instructions, facilities may not perform the full maintenance schedule needed to keep the devices in proper working order.
- Check if your samaritan PAD model number is 350P, 360P, or 450P and matches one of the affected serial numbers
- Contact HeartSine Technologies for the Maintenance Supplement document if you have an affected device
- Ensure your device receives both monthly and quarterly maintenance checks as directed
- Review the supplement instructions once received to understand the complete maintenance schedule
The agency's original wording
Hazard
Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.
Intended for
All ages
Illnesses reported
None reported
Sold states
U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
Affected count
31,834
Manufactured in
207 Airport Road West, Belfast, United Kingdom
Products
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: 0506016712207 350P US Device, US English with Gateway - 2 Min CPR UDI-DI code: 0506016712804 HeartSine SAM 360P 360P US Device, US English - 2 Min CPR UDI-DI code: 0506016712068 HeartSine SAM 450P SAM 450P US Device, US English (2 min CPR) UDI-DI code: 0506016712069
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3270-2026More HeartSine recalls
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