LivaNova Deutschland GmbH
MUNCHEN Bavaria, DE
LivaNova Deutschland GmbH appears in FDA device records in MUNCHEN Bavaria, DE. FDA records list 27 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 15 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to LivaNova Deutschland GmbH carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Sorin Group Deutschland GmbH510(k), enforcement report, recall
510(k) clearance history
FDA records hold 27 510(k) clearances for LivaNova Deutschland GmbH between 2006 and 2023. The busiest year on record is 2011, with 5. The most recent is 2023, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 3 |
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 3 |
| 2010 | 2 |
| 2011 | 5 |
| 2013 | 1 |
| 2014 | 2 |
| 2017 | 1 |
| 2020 | 1 |
| 2021 | 3 |
| 2022 | 1 |
| 2023 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232291 | Essenz HLM, Essenz ILBM | DTQ | Substantially Equivalent | |
| K221373 | Essenz HLM | DTQ | Substantially Equivalent | |
| K220635 | Heater-Cooler System 3T | DWC | Substantially Equivalent | |
| K212003 | ESSENZ Patient Monitor | DXJ | Substantially Equivalent | |
| K210130 | Stockert S5 System | DTQ | Substantially Equivalent | |
| K202154 | B-Capta | DRY | Substantially Equivalent | |
| K191402 | Heater-Cooler System 3T | DWC | Substantially Equivalent | |
| K170460 | Sorin Connect | DXJ | Substantially Equivalent | |
| K131553 | XTRA | CAC | Substantially Equivalent | |
| K140012 | SORIN FLEXTHERM | DWC | Substantially Equivalent | |
| K131816 | SORIN CONNECT DATA MANAGEMENT SYSTEM | DXJ | Substantially Equivalent | |
| K112225 | SORIN CENTRIFUGAL PUMP 5 (CP5) | DWA | Substantially Equivalent | |
| K103762 | SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE | DTQ | Substantially Equivalent | |
| K103468 | STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) | DWA | Substantially Equivalent | |
| K103469 | STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 | KRL | Substantially Equivalent | |
| K103168 | B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) | DRY | Substantially Equivalent | |
| K101046 | STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM | DTX | Substantially Equivalent | |
| K093882 | SORIN C5 SYSTEM MODEL 58-00-00 | DTQ | Substantially Equivalent | |
| K092463 | SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM | DTQ | Substantially Equivalent | |
| K091008 | STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55 | DWA | Substantially Equivalent | |
| K091007 | AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05 | DTQ | Substantially Equivalent | |
| K082344 | STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO) | DWF | Substantially Equivalent | |
| K080832 | STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER | DTQ | Substantially Equivalent | |
| K071318 | MODIFICATION TO: STOCKERT S5 SYSTEM | DTQ | Substantially Equivalent | |
| K062396 | MODIFICATION TO STOCKERT S5 SYSTEM | DTQ | Substantially Equivalent | |
| K052601 | STOCKERT HEATER-COOLER SYSTEM 3T | DWC | Substantially Equivalent | |
| K060053 | STOCKERT S5 SYSTEM | DTQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9611109 | 3002808267 | LivaNova Deutschland GmbH | LINDBERGH STRASSE 25, MUNCHEN Bavaria 80939 DE | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KRIAccessory Equipment, Cardiopulmonary Bypass
- CACApparatus, Autotransfusion
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass
- DWAControl, Pump Speed, Cardiopulmonary Bypass
- DWCController, Temperature, Cardiopulmonary Bypass
- KRLDetector, Bubble, Cardiopulmonary Bypass
- DXJDisplay, Cathode-Ray Tube, Medical
- DTXGas Control Unit, Cardiopulmonary Bypass
- DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0571-2025 | 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. | Class II | Open, Classified | |
| Z-0073-2024 | 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. | Class II | Open, Classified | |
| Z-0787-2022 | 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. | Class III | Terminated | |
| Z-2440-2020 | 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. | Class II | Terminated | |
| Z-2439-2020 | 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. | Class II | Terminated | |
| Z-0401-2018 | CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used with an Electrical Remote-Controlled (ERC) tubing clamp and a bubble sensor. | Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after detection of an air bubble could take longer than is intended by design in the CP5 system. | Class II | Terminated | |
| Z-0857-2014 | CP5 centrifugal pump system Product Usage: The Stockert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. | Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response. | Class II | Terminated | |
| Z-0856-2014 | S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. | Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response. | Class II | Terminated | |
| Z-0142-2014 | S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less. | Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control. | Class II | Terminated | |
| Z-1330-2012 | Sorin C5 (perfusion system) The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. | The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. Insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump speed control knob. Excessive friction causes premature wear of the encoder shaft which can result in a stuck shaft. | Terminated | ||
| Z-1329-2012 | Pump control panel. The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. | The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. Insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump speed control knob. Excessive friction causes premature wear of the encoder shaft which can result in a stuck shaft. | Terminated | ||
| Z-1328-2012 | Control panel for mast roller pump 85 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. | The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. Insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump speed control knob. Excessive friction causes premature wear of the encoder shaft which can result in a stuck shaft. | Terminated | ||
| Z-1327-2012 | Control panel for mast roller pump 150/85 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. | The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. Insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump speed control knob. Excessive friction causes premature wear of the encoder shaft which can result in a stuck shaft. | Terminated | ||
| Z-1326-2012 | S5 Double Roller Pump 85 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. | The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. Insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump speed control knob. Excessive friction causes premature wear of the encoder shaft which can result in a stuck shaft. | Terminated | ||
| Z-1325-2012 | S5 Single Roller Pump 150 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. | The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. Insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump speed control knob. Excessive friction causes premature wear of the encoder shaft which can result in a stuck shaft. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain