LivaNova recalls SCP Pump Control Panel S5/C5 models with serial numbers 60S14735-60S14755. Premature angle encoder wear may cause stroke, organ damage, or tissue injury during heart surgery. Stop using immediately.
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.
LivaNova is recalling SCP Pump Control Panel S5/C5 models that may have a faulty angle encoder. This could cause stroke, organ damage, or tissue injury during cardiopulmonary bypass surgery if the control panel fails.
The angle encoder in the control panel may wear out prematurely, causing the knob to become difficult or impossible to rotate. If this happens during heart surgery, it could lead to stroke, organ damage, or tissue injury because the pump control fails.
Heart surgery patients using the SCP control panel with serial numbers 60S14735 through 60S14755 are most at risk. Medical teams operating the equipment during cardiopulmonary bypass procedures are affected.
Check for serial numbers 60S14735, 60S14736, 60S14755, 60S14707, 60S14708, 60S14715, 60S14716, or 60S14735 on the control panel. The product is sold under the LivaNova SCP Pump Control Panel S5/C5 model with reference number 60-02-50.
The control panel may cause serious injury during surgery if the angle encoder fails. Do not use the panel until a replacement is received.
The recalled model is LivaNova SCP Pump Control Panel S5/C5 with reference number 60-02-50.
Failure could lead to stroke, organ damage, arterial tissue injury, or reperfusion syndrome.
Check the serial number on the panel; affected units have serial numbers 60S14735 through 60S14755.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-2439-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-2439-2020 from LivaNova. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
