Z-1326-2012

S5 Double Roller Pump 85 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood...

Name: Z-1326-2012 S5 Double Roller Pump 85 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood...
Creator: Sorin Group Deutschland GmbH
Published: 2012-02-23
License: https://open.fda.gov/license/

LivaNova Deutschland GmbH / initiated 2012-02-23 / Terminated / root cause: manufacturing process

FDA source

Sorin Group Deutschland GmbH began a recall of S5 Double Roller Pump 85 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6)... on 2012-02-23. The reason FDA records is "The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. Insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1326-2012
Status: Terminated
Initiated: 2012-02-23
Posted: 2012-03-29
Terminated: 2012-11-27
Recalling firm: LivaNova Deutschland GmbH
Product: S5 Double Roller Pump 85 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. Insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump speed control knob. Excessive friction causes premature wear of the encoder shaft which can result in a stuck shaft.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Sorin Group sent an Urgent Field Safety Notice dated February 23, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: Before each use of the device during the set-up procedure, rotate all pump speed control knobs back and forth to check for smooth operation. If abnormal friction or any binding is detected, please do not use the system until it is repaired. If an affected product is currently in use with a patient and an increase of friction is detected please prepare for a replacement pump. Please complete and return the attached Confirmation Form by fax to 303-467-6502. Customers were instructed to ensure that the Urgent Field Safety Notice is distributed to all personnel in their organization who need to be aware of the notice. If the product was transferred to a third party, customers were asked to share the information with them as well as Sorin Group USA Customer Service at 1-800-850-2623. For questions regarding this Urgent Field Safety Notice, contact Sorin Group USA Customers Service at 1-800-650-2623. All affected customers and distributors were notified of the Field Correction by certified mail beginning on February 23, 2012. They will be contacted by Sorin Service Group to arrange an appointment to replace affected shaft encoders on site.
Quantity in commerce: 251
Distribution: Worldwide Distribution
Product codes and lots: 10E51342 to 10E51597

Product code DTQ

K071318Class IIModification to: Stockert S5 SystemSorin Group Deutschland GmbH / cleared 2007-07-06

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)