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LivaNova Deutschland Recalls
5 recalls on record · July 8, 2020 to December 4, 2024 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 4, 2024Medical DevicesFDA
LivaNova Deutschland GmbH recalls Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
Hazard: Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to gas blender standby, then gas blender must be reactivated using user interface on blender, sensors deactivated until new case started; GUI reset can lead to Hypoxia and Hypoperfusion.
October 18, 2023Medical DevicesFDA
LivaNova Deutschland GmbH recalls 3T Heater Cooler System, REF: 16-02-85
Hazard: The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.
March 23, 2022Medical DevicesFDA
LivaNova Deutschland GmbH recalls Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 Syst
Hazard: One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
July 8, 2020Medical DevicesFDA
LivaNova Deutschland GmbH recalls Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986
Hazard: 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.
July 8, 2020Medical DevicesFDA
LivaNova Deutschland GmbH recalls Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993
Hazard: 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.