Sorin S5 Perfusion System Recalled for Motor Controller Fault
Sorin Group USA is recalling S5 Perfusion Systems due to a motor controller fault that may cause unintended pump stoppage during surgery.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the defect may result in permanent impairment or life-threatening injury, which aligns with the rubric criteria for Severe severity involving significant injury reports or risks.
Plain-English summary
Sorin Group USA, Inc. has issued an Urgent Field Safety Notice for specific serial numbers of the S5 Perfusion System. The recall is due to reports of a "Fault in motor controller" alarm message appearing on the system panel. This issue is attributed to an out-of-specification electrical component.
The S5 Perfusion System is intended for use during cardiopulmonary bypass procedures lasting six hours or less. The motor controller fault could lead to unintended pump stoppage, which may result in permanent impairment or life-threatening injury to patients.
The affected units were distributed worldwide, including in the United States and numerous international countries. The recall involves 5 units with specific serial numbers listed in the agency record. Healthcare providers should check their inventory against the provided serial numbers and contact Sorin Group USA for further instructions.
The recalled product
- Product
- S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
- Manufacturer
- Sorin Group USA, Inc.
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Serial Numbers: 10E51854
- 10E51856-10E51858
- 10E51860
- 10E51861
- 10E51864
- 10E51867
- 10E51870
- 10E51871
- 10E51873
- 10E51880-10E51897
- 10E51899-10E51913.
Distribution
Part of a larger recall action
This product is one of 5 recalled by Sorin Group USA, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Sorin Group USA, Inc.
See all →- HighSorin FlexFlow Venous Cannula Recalled for Sharpness Defect
FDA (Devices) · 2017-11-15
- HighSorin Group Aortic Arch Cannula Recalled for Excess Plastic on Tip
FDA (Devices) · 2017-08-16
- HighLivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09
- HighLivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09
- HighLivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09
Same hazard · pump stoppage
See all →- HighHeartWare HVAD ventricular assist pump driveline cover hardening recall
FDA (Devices) · 2022-12-28
- SevereSorin C5 Perfusion System Recalled for Motor Controller Fault
FDA (Devices) · 2012-11-14