Stryker recalls AEDs due to malfunction risk

Stryker is recalling nearly 12,000 HeartSine automated external defibrillators (AEDs) due to a risk of the devices failing to deliver the intended therapy. If such a failure does occur, it could lead to therapy being delayed or not being delivered at all. 

This recall includes specific lots of the HeartSine Samaritan PAD 450P, HeartSine Samaritan PAD 360P and HeartSine Samaritan PAD 350P. These Wi-Fi-enabled devices were designed to help first responders provide care to cardiac arrest patients who may be unconscious or not breathing. They guide users through the process so that even someone with no experience with an AED can still deliver potentially life-saving care. 

Stryker emphasized in a message to customers that this malfunction risk has not been linked to any adverse events. The company identified the problem during internal quality testing and initiated the voluntary recall “out of an abundance of caution.”

The U.S. Food and Drug Administration (FDA) ruled that this is a Class II recall. This means the devices “may cause temporary or medically reversible adverse health consequences” or “the probability of serious adverse health consequences is remote.”

What caused the recall?

Stryker found that an internal component of these devices, the membrane tail, was associated with an increased risk of malfunctioning. These malfunctions could occur when the AED is holding a charge, when it is delivering a shock, or after the shock has been delivered.

Stryker is currently working to replace these devices for its customers. 

“Stryker has notified all customers who received affected HeartSine Samaritan PAD devices with the complete instructions to submit a response,” a Stryker spokesperson told Cardiovascular Business. “Once we receive a customer’s response and a replacement device is available, we will contact them as soon as possible to arrange next steps.”