LivaNova SCP Pump Control Panel Recalled Due to Rotary Knob Wear
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.
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 source text explicitly lists potential severe injuries including stroke, organ damage, and arterial tissue injury, which aligns with the rubric criterion for 'significant injury' reports or risks.
Plain-English summary
LivaNova Deutschland GmbH is recalling 24 units of the LivaNova SCP Pump Control Panel (REF 60-02-15). The recall involves specific serial numbers listed in the agency's structured data. The product is a 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 rotary 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 bypass, 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 (including Canada, Uzbekistan, Turkey, and others). Healthcare providers should stop using the affected control panels and contact LivaNova for instructions on replacement or repair.
The recalled product
- Product
- Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986
- Manufacturer
- LivaNova Deutschland GmbH
- Affected units
- 24
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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