FDA (Devices) recall action 85505
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrifugal pump during cardiopulmonary bypass may be difficult or impossible to rotate as a result of premature wear of the angle encoder. The loss of function of the angle encoder during bypass may lead to ischemia, stroke, organ damage, arterial tissue injury or reperfusion syndrome.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
LivaNova is recalling eight SCP Pump Control Panels because premature wear of the angle encoder may make the rotary knob difficult or impossible to rotate during cardiopulmonary bypass.
LivaNova is recalling 24 SCP Pump Control Panels because the rotary knob may fail to rotate due to premature wear, risking patient injury during surgery.