Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15 Recalled by LivaNova Deutschland GmbH Due to The SCP control Panel rotary knob used to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact LivaNova Deutschland GmbH directly.
Affected Products
Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986
Quantity: 24
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 13 states: FL, GA, IN, KY, MI, MO, NY, OH, PA, SC, TN, TX, VA
About LivaNova Deutschland GmbH
LivaNova Deutschland GmbH has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report