LivaNova recalls SCP Pump Control Panel REF 60-02-15 due to potential angle encoder failure causing stroke, organ damage, or arterial injury during heart surgery. Affected units have specific serial numbers and UDI codes.
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 Panels with serial numbers starting with 60S that may have a faulty angle encoder. If the knob becomes difficult to rotate during heart surgery, it could cause stroke, organ damage, or arterial injury.
The rotary knob controlling pump speed may become stuck due to premature wear in the angle encoder. If it fails during surgery, it could cause blood flow issues leading to stroke, organ damage, or arterial injury.
Heart surgery patients using the SCP system with the recalled control panels. Medical professionals who operate the pump during cardiopulmonary bypass are most at risk.
Check for serial numbers starting with 60S (e.g., 60S14838, 60S14839). The unique device identifier (UDI) is 04033817900986. These panels were sold with the REF 60-02-15 model.
Immediately stop using the SCP Pump Control Panel if it is difficult to rotate the rotary knob during cardiopulmonary bypass procedures.
The recalled model is REF 60-02-15 with serial numbers starting with 60S (e.g., 60S14838, 60S14839).
Check if your serial number starts with 60S (e.g., 60S14838) and the unique device identifier (UDI) is 04033817900986.
The loss of function could lead to ischemia, stroke, organ damage, arterial tissue injury, or reperfusion syndrome.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-2440-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-2440-2020 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.
