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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
See all 2 products in this recall →Related recalls
Same manufacturer · LivaNova Deutschland GmbH
See all →- HighEssenz HLM Heart-Lung Machines May Fail Due to Software Defect
FDA (Devices) · 2024-12-04
- Moderate3T Heater Cooler System Recalled for Incorrect Maintenance Schedule Information
FDA (Devices) · 2023-10-18
- ModerateSorin Centrifugal Pump CP5 Drive Unit missing electromagnetic shielding component
FDA (Devices) · 2022-03-23
- SevereLivaNova SCP Pump Control Panel Recalled Due to Rotary Knob Wear
FDA (Devices) · 2020-07-08
Same hazard · mechanical failure
See all →- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighForest River Transit Buses Recalled for Wheelchair Lift Control Failure
NHTSA · 2026-09-01
- HighBlue Bird Recalls Vision School Buses Due to Wheelchair Lift Defect
NHTSA · 2026-08-31
- SevereMagic Tilt Watercraft Trailers Recalled Due to Winch Weld Failure
NHTSA · 2026-08-28