Health Canada is recalling certain HeartSine Samaritan defibrillator devices sold at Costco due to the failure of an internal component.
The affected devices are HeartSine Samaritan PAD SAM 350P, SAM 360P, and SAM 500P automated external defibrillators (AED).
Costco issued an “urgent medical device recall” for the impacted items that were sold with numbers 1116470, 2116470, 1116561 and 2116561.
Stryker, the distributor and manufacturer of HeartSine AEDs, identified a problem with the membrane tail that could cause an internal component to malfunction in the portable, battery-operated device designed to treat victims of cardiac arrest.
According to Health Canada’s notice, this issue can happen at any point including when a device is delivering a shock or in preparation to deliver a shock. This results in the device being inoperable.
“This issue was observed during non-standard rework process and quality testing, not during patient use,” according to Stryker’s recall notice.
There have been no reported incidents or injuries caused by the affected devices.
Devices with the following model numbers are being recalled. Since there are more than 10 serial numbers per model, customers are being asked to call the manufacturer.
- 350-TSO-CN-10
-
350-BAS-CN-10
- 350-BAS-CF-10
- 350-STR-CN-10
- 360-BAS-CN-10
- 360-BAS-CF-10
- 360-STR-CN-10
- 360-TSO-CN-10
- 500-STR-CN-10
- 500-BAS-CN-10
Stryker is asking those with an affected product to complete and return the recall acknowledgment to [email protected] by Aug. 31, 2026. Customers are also being asked to download and keep the attached maintenance supplement with the AED user manual until the replacement device arrives. The company recommends those without another defibrillator device to continue using this one.
“Stryker’s testing indicates the likelihood of failure is very low, and having an AED available remains safer than having none,” said the company’s notice.
