Z-0271-2013Class II

S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used...

Name: Z-0271-2013 S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used...
Creator: Sorin Group USA, Inc.
Published: 2012-09-19
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2012-09-19 / Terminated

FDA source

Sorin Group USA, Inc. began a recall of 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... on 2012-09-19. FDA classified it as Class II and gives the reason as "Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0271-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-19
Posted: 2012-11-08
Terminated: 2013-01-18
Recalling firm: LivaNova USA, Inc.
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.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determi
FDA root cause: Mixed-up of materials/components
Action: The firm, Sorin Group, sent an "URGENT FIELD SAFETY NOTICE" dated September 19, 2012 to all affected customers by certified mail. The notice described the product, problem and actions to be taken. The customers were instructed to follow the provided instructions for the continued safe use of the Perfusion systems until they have been serviced or replaced by Sorin Group. The Sorin Group Service Team will contact the customer to schedule servicing and replacement of the affected product. The customers were also instructed to complete and return the Customer Response Form via fax to 303-467-6502 or by email to [email protected]; assure this notice is distributed to all personnel who need to be aware of this notice; and if they have transferred the affected products to a third party, pass this information with them as well as with Sorin Group Customer Service at 1-800-650-2623. For questions regarding this notice, contact Sorin Group USA Customer Service at 1-800-650-2623.
Quantity in commerce: 35 units
Distribution: Worldwide distribution: USA (nationwide) including states of: AZ, GA, MI, MS, NC, NY, PA, SC, and TX; and countries of: Austria, Australia, Belgium, Canada, People's Republic of China, Columbia, Denmark, Finland, Germany, India, Iran-Islamic Republic of, Ireland, Japan, Lebanon, Morocco, Pakistan, Poland, Russian Federation, Saudia Arabia, Spain, South Africa, Thailand, Turkey and United Kingdom.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0271-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0271-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-08
Z-0272-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-08
Z-0273-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-08
Z-0274-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-08
Z-0275-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-08

Product code DTQ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)