Recall number
PR3977961–FA318
Product description:
The HeartSine Samaritan PAD is a small, lightweight, portable, battery operated Automated External Defibrillator (AED) designed to treat victims of cardiac arrest.
Product affected:
Affected devices include a subset of Samaritan PAD Models 350P, 360P, 450P, 500P that were manufactured in 2022, 2023, 2024.
Product issue:
It was determined during rigorous quality testing that a manufacturing process related issue may impair the device’s ability to function or cause failure.
Potential risks:
If this issue occurs, the device may fail to deliver the intended therapy during use, potentially leading to a delay in treatment or no treatment being delivered during use.
The issue was observed during quality testing, not during patient use. There have been no adverse events reported related to this product issue.
Is your product affected?
To find your device serial number and model number, see the labels on the rear of your device as shown below:
Impacted devices have both of the following:
- Model number 350, 360, 450, or 500
- Serial numbers beginning with 21, 22, 23, 24, then followed by letter B, D, E, or G
Serial numbers affected
Open the PDF that corresponds to the first two numbers of the serial number and search for your serial number. Or, press "Control+F" (or "Command+F" on a Mac) to find on page.
