Sorin Group Deutschland GmbH
Country not established
- Devices
- 20
- FDA recalls
- 10
At a glance
Market reach
- United States
- FDA recalls
What Sorin Group Deutschland GmbH makes
The manufacturer produces modifications and upgrades for the Stockert S5 system, including air purge control systems, electrical venous occluders, and gas blenders. Their portfolio also includes standalone systems like the Stockert Centrifugal Pump Plus (SCP Plus) and the Sorin C5 Mast Roller Pump System, alongside peripheral components such as venous sensors and measuring heads for extracorporeal circulation devices. Additional offerings include the Sorin Connect platform and the Sorin FlexTherm, likely for temperature management in cardiac procedures.
These devices are classified under Class II by the FDA and are recorded in the 510(k) premarket notification registry. The manufacturer operates from the United States.
Catalogue
Search and filter all 20 devicesFDA recalls
FDA recall records list 10 recalls initiated by Sorin Group Deutschland GmbH, the earliest on 2012-02-23 and the most recent on 2017-10-30. By recorded status: 10 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 1
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 30 Oct 2017 Z-0401-2018 Class II Terminated 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.
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- 30 Oct 2017 Z-0401-2018 Class II Terminated 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.
2013
- 4 Dec 2013 Z-0856-2014 Class II Terminated 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.
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- 4 Dec 2013 Z-0857-2014 Class II Terminated 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.
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- 24 Sep 2013 Z-0142-2014 Class II Terminated Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.
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- 4 Dec 2013 Z-0856-2014 Class II Terminated 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.
2012
- 23 Feb 2012 Z-1325-2012 Not yet classified Terminated 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.
- 23 Feb 2012 Z-1326-2012 Not yet classified Terminated 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.
- 23 Feb 2012 Z-1327-2012 Not yet classified Terminated 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.
- 23 Feb 2012 Z-1328-2012 Not yet classified Terminated 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.
- 23 Feb 2012 Z-1329-2012 Not yet classified Terminated 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.
- 23 Feb 2012 Z-1330-2012 Not yet classified Terminated 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.
Frequently asked questions
How many devices does Sorin Group Deutschland GmbH have in the registry?
The registry currently lists 20 devices for Sorin Group Deutschland GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sorin Group Deutschland GmbH's devices?
Among its 20 most recently registered devices, Sorin Group Deutschland GmbH has devices listed in FDA 510(k) (20 devices).
What risk classes do Sorin Group Deutschland GmbH's devices fall under?
Among its 20 most recently registered devices, the classes recorded for Sorin Group Deutschland GmbH's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Sorin Group Deutschland GmbH?
FDA recall records list 10 recalls initiated by Sorin Group Deutschland GmbH, the most recent initiated on 30 Oct 2017. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Sorin Group Deutschland GmbH in the registry?
The most recently registered devices listed for Sorin Group Deutschland GmbH include MODIFICATION TO STOCKERT S5 SYSTEM, MODIFICATION TO: STOCKERT S5 SYSTEM, SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE and AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05.