Livanova Deutschland Gmbh
FDA adverse event reports naming Livanova Deutschland Gmbh as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: LIVANOVA DEUTSCHLAND GMBH.
- Total reports
- 1,226
- Deaths
- 33
- Injuries
- 105
- Malfunctions
- 1,088
Reports per year
Source: FDA adverse event reports by year received, 2018–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Controller, Temperature, Cardiopulmonary BypassDWC666
- Console, Heart-Lung Machine, Cardiopulmonary BypassDTQ290
- Gas Control Unit, Cardiopulmonary BypassDTX74
- Control, Pump Speed, Cardiopulmonary BypassDWA68
- Pump, Blood, Cardiopulmonary Bypass, Roller TypeDWB66
- Pump, Blood, Cardiopulmonary Bypass, Non-Roller TypeKFM21
- Clamp, VascularDXC16
- Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDWF14
- Detector, Bubble, Cardiopulmonary BypassKRL4
- Monitor And/Or Control, Level Sensing, Cardiopulmonary BypassDTW3
Recent recalls
- 2024-11-27Open, ClassifiedSoftware change control
Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
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.
- 2023-10-06Open, ClassifiedLabeling Change Control
3T Heater Cooler System, REF: 16-02-85
The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.
- TerminatedProcess control
Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device.
One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
- TerminatedDevice Design
Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993
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.
- TerminatedDevice Design
Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986
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.
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