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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 (score 4) involving significant injury reports or risks.
Plain-English summary
Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System. The recall is due to reports of a "Fault in motor controller" alarm message displayed 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 for procedures lasting six hours or less. The identified defect could lead to unintended pump stoppage, which may result in permanent impairment or life-threatening injury to patients.
The recall involves 3 units distributed worldwide, including the United States and various international locations. Affected serial numbers are 50E50766-50E50769, 50E50772-50E50774, and 50E50783-50E50784. Users should check their equipment serial numbers against this list and contact the manufacturer for instructions.
The recalled product
- Product
- S5 Mast Roller Pump 85, Item Number: 10-88-60 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
- 3
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 (3)
- Serial Numbers: 50E50766--50E50769
- 50E50772-50E50774
- 50E50783-50E50784.
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.
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