FDA recall, , Moderate risk
HeartSine Samaritan PAD Defibrillators SAM 350P, SAM 360P and SAM 450P
HeartSine SAM 350P, SAM 360P, and SAM 450P defibrillators have a damaged membrane tail causing an intermittent fault.
Summary by Recall Canary from the FDA notice
What happened
HeartSine Technologies Ltd of Belfast, United Kingdom recalled HeartSine SAM 350P, SAM 360P, and SAM 450P devices because a damaged (over stretched) membrane tail causes an intermittent fault. The FDA added the recall to its Enforcement Report on September 4, 2026, and the company began the recall on July 27, 2026. Distribution included U.S. nationwide states such as Alaska, California, Florida, and New York, and worldwide countries including Canada, Japan, and the United Kingdom.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
SAM 450P US Device, US English (2 min CPR)
- UDI-DI
- 0506016712069
350P US Device, US English - 2 Min CPR
- UDI-DI
- 0506016712067
350P US Device, US English (American Airlines) - 2 Min CPR
- UDI-DI
- 0506016712207
350P US Device, US English with Gateway - 2 Min CPR
- UDI-DI
- 0506016712804
360P US Device, US English - 2 Min CPR
- UDI-DI
- 0506016712068
Recall details
- Company began the recall
- Sold in
Worldwide - U.S. Nationwide distribution including in the states of Alaska, Alabama, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine Michigan, Minnesota, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota,Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming. The countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Hong Kong, Indonesia, ISRAEL, JAPAN, Malaysia, Netherlands, Philippines, POLAND, SINGAPORE, South Korea, Taiwan, Thailand and UNITED KINGDOM.
- Company
- HeartSine Technologies LtdBelfast, United Kingdom
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99568
- Recall number
- Z-3120-2026
All recalls from HeartSine Technologies Ltd
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
