Agency classClass IIOur severity:Severe FDA (Devices)·Z-0274-2013·Announced 2012-11-14

Sorin S5 Perfusion System Recalled for Motor Controller Faults

Sorin Group USA is recalling S5 Perfusion Systems due to a motor controller fault that could 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 a Severe (4) rating 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. The affected product is the S5 Mast Roller Pump 150, Item Number 10-88-00, which is part of the Stockert S5/Sorin C5 System intended for use during cardiopulmonary bypass for procedures lasting six hours or less.

The defect involves an out-of-specification electrical component that could lead to unintended pump stoppage. This failure may result in permanent impairment or life-threatening injury to patients undergoing surgery. The agency classification for this recall is Class II.

The affected units were distributed worldwide, including nationwide in the United States and in numerous other countries such as Austria, Australia, Belgium, Canada, China, and the United Kingdom. Specific serial numbers affected include 50E00680-50E00681, 50E00688, 50E00696-50E00706, and 50E00708-50E00718. Healthcare facilities should check their inventory for these serial numbers and follow the instructions provided in the Urgent Field Safety Notice.

The recalled product

Product: S5 Mast Roller Pump 150, Item Number: 10-88-00 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.
Category: Medical Device — Cardiopulmonary Bypass
Hazard: equipment-failure
life-threatening-injury
Affected units: 2

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 (4)

Serial Numbers: 50E00680--50E00681
50E00688
50E00696-50E00706
50E00708-50E00718.

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

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 →

Same manufacturer · Sorin Group USA, Inc.

See all →

High
Sorin FlexFlow Venous Cannula Recalled for Sharpness Defect
FDA (Devices) · 2017-11-15
High
Sorin Group Aortic Arch Cannula Recalled for Excess Plastic on Tip
FDA (Devices) · 2017-08-16
High
LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09
High
LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09
High
LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09

Same hazard · equipment failure