LivaNova SCP Pump Control Panel Recalled for Rotary Knob Wear
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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a critical life-support device that can lead to severe injuries such as stroke, organ damage, and ischemia, meeting the criteria for a Severe rating.
Plain-English summary
LivaNova Deutschland GmbH is recalling eight units of the LivaNova SCP Pump Control Panel S5/C5 (REF 60-02-50). The recall involves specific serial numbers: 60S14735, 60S14877, 60S14715, 60S14716, 60S14736, 60S14755, 60S14707, and 60S14708. The product is a prescription-only medical device used as a centrifugal pump during cardiopulmonary bypass.
The recall is due to a defect where the rotary knob used to control the pump's speed may be difficult or impossible to rotate. This issue is caused by premature wear of the angle encoder. If the angle encoder loses function during a bypass procedure, it may lead to ischemia, stroke, organ damage, arterial tissue injury, or reperfusion syndrome.
The affected units were distributed in the United States (FL, GA, IN, KY, MI, MO, NY, OH, PA, SC, TN, TX, VA) and internationally to Canada, Uzbekistan, Turkey, Tunisia, Taiwan, South Africa, Serbia, Saudi Arabia, Russia, Poland, Mexico, Korea (Rep. of), India, Hong Kong, Colombia, China, Brazil, Bahrain, Argentina, Algeria, Italy, and Germany. Healthcare facilities and users should stop using the affected control panels and contact LivaNova for instructions on replacement or repair.
The recalled product
- Product
- Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993
- Manufacturer
- LivaNova Deutschland GmbH
- Affected units
- 8
Distribution
Part of a larger recall action
This product is one of 2 recalled by LivaNova Deutschland GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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