Sorin Group Deutschland
FDA adverse event reports naming Sorin Group Deutschland as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: SORIN GROUP DEUTSCHLAND.
- Total reports
- 2,954
- Deaths
- 44
- Injuries
- 88
- Malfunctions
- 1,245
Reports per year
Source: FDA adverse event reports by year received, 2007–2017. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Console, Heart-Lung Machine, Cardiopulmonary BypassDTQ1,652
- Controller, Temperature, Cardiopulmonary BypassDWC538
- Pump, Blood, Cardiopulmonary Bypass, Roller TypeDWB319
- Control, Pump Speed, Cardiopulmonary BypassDWA260
- Gas Control Unit, Cardiopulmonary BypassDTX89
- Monitor And/Or Control, Level Sensing, Cardiopulmonary BypassDTW38
- Pump, Blood, Cardiopulmonary Bypass, Non-Roller TypeKFM31
- Detector, Bubble, Cardiopulmonary BypassKRL15
- Apparatus, AutotransfusionCAC5
- Oxygenator, Cardiopulmonary BypassDTZ4
Recent recalls
- 2014-01-28TerminatedDevice Design
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.
- 2014-01-28TerminatedDevice Design
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.
- 2013-11-04TerminatedSoftware Manufacturing/Software Deployment
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.
- 2012-03-29TerminatedNonconforming Material/Component
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.
- 2012-03-29TerminatedNonconforming Material/Component
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.
- 2012-03-29TerminatedNonconforming Material/Component
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.
- 2012-03-29TerminatedNonconforming Material/Component
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.
- 2012-03-29TerminatedNonconforming Material/Component
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.
- 2012-03-29TerminatedNonconforming Material/Component
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.
- TerminatedDevice Design
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.
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