The Recall Desk
SevereFDA (Devices)·Z-0275-2013·Announced 2012-11-14

Sorin C5 Perfusion System Recalled for Motor Controller Fault

Sorin Group USA recalled two Sorin C5 Perfusion Systems due to a motor controller fault that could cause 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 a Severe (4) rating involving significant injury reports or potential for serious harm.

Plain-English summary

Sorin Group USA, Inc. has issued an Urgent Field Safety Notice for specific serial numbers of the Sorin C5 Perfusion System. The recall is due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This fault could lead to unintended pump stoppage, which may result in permanent impairment or life-threatening injury. The issue was caused by an out-of-specification electrical component.

The affected product is the Sorin C5 Perfusion System, Item number 58-00-00, intended for use during cardiopulmonary bypass for procedures lasting six hours or less. The recall involves two units with serial numbers 58E00135 and 58E00136. The source text notes that no product was distributed within the US, although the distribution pattern lists worldwide distribution including the USA and various international countries.

Healthcare providers should check their inventory for the affected serial numbers. If the product is found, it should be removed from service and returned to Sorin Group USA, Inc. according to the instructions in the Urgent Field Safety Notice.

The recalled product

Product
Sorin C5 Perfusion System, Item number 58-00-00 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
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 (2)

  • Serial Numbers: 58E00135
  • 58E00136

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 →

Related recalls

Same manufacturer · Sorin Group USA, Inc.

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Same hazard · pump stoppage

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