FDA Update: LIFEPAK 15 Monitor/Defibrillators Recalled Due to Shock Failure

On Jan. 10, B. Stryker initiated a voluntary recall of specific units of their LIFEPAK 15 monitor/defibrillators due to an issue that may cause these devices to fail to deliver a defibrillation shock after the "shock" button on the keypad is pressed.

Stryker is contacting customers with impacted devices to schedule the correction of their device(s), which will include replacement of the affected keypad, and anticipates that all subjected devices will be serviced by June 2021.

According to Stryker, most complaints associated with this issue were detected prior to patient use. Read the full U.S. Food and Drug Administration announcement and learn how to report device failure here.

Clinical Topics: Arrhythmias and Clinical EP, Implantable Devices, SCD/Ventricular Arrhythmias

Keywords: ACC Advocacy, United States Food and Drug Administration, Defibrillators, Equipment Failure

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