The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0271-2013·Announced 2012-11-14

Sorin S5 Perfusion System Recalled for Motor Controller Faults

Sorin Group USA is recalling S5 Perfusion Systems due to motor controller faults 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 criterion for Severe (4) involving significant injury reports or high-risk medical device defects.

Plain-English summary

Sorin Group USA, Inc. has issued an Urgent Field Safety Notice for 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 could lead to unintended pump stoppage, which may result in permanent impairment or life-threatening injury. The source text indicates that an out-of-specification electrical component was determined to be the cause.

The affected product is the S5 Single Roller Pump 150 (Item Number: 10-80-00), part of the Stockert S5/Sorin C5 System intended for use during cardiopulmonary bypass for procedures lasting six hours or less. A total of 35 units are involved in this recall. The specific serial numbers affected are listed in the source metadata, including ranges such as 10E06219, 10E06220, and 10E06231-10E06234.

Distribution was worldwide, including the United States (nationwide, with specific mentions of AZ, GA, MI, MS, NC, NY, PA, SC, and TX) and numerous international countries such as Austria, Australia, Belgium, Canada, China, and the United Kingdom. Healthcare facilities and users should check their equipment serial numbers against the provided list and contact Sorin Group USA for further instructions.

The recalled product

Product
S5 Single Roller Pump 150, Item Number: 10-80-00 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
35

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 (15)

  • Serial Numbers: 10E06219
  • 10E06220
  • 10E06231-10E06234
  • 10E06239-10E06241
  • 10E06255-10E06273
  • 10E06286-10E06289
  • 10E06291-10E06355
  • 10E06359-10E06364
  • 10E06366
  • 10E06368-10E06383
  • 10E06385
  • 10E06387-10E06391
  • 10E06395-10E06401
  • 10E06403-10E06447
  • 10E6502.

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 →

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