HeartSine Technologies recalled 11,912 HeartSine samaritan PAD automated external defibrillators because an intermittent fault can render the devices inoperable.
The Class II recall covers HeartSine SAM 350P, SAM 360P and SAM 450P models, according to an FDA notice posted Sept. 4. The company initiated the recall July 27.
The issue involves a damaged, overstretched membrane tail that can cause an intermittent fault. The failure can occur while the device is holding a charge, delivering a shock or after a shock is delivered. The device becomes inoperable after the failure occurs.
The devices are indicated for cardiac arrest patients who are unconscious, not breathing and have no circulation.
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