Z-0401-2018Class II

CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used...

Name: Z-0401-2018 CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used...
Creator: Sorin Group Deutschland GmbH
Published: 2017-10-30
License: https://open.fda.gov/license/

LivaNova Deutschland GmbH / initiated 2017-10-30 / Terminated / root cause: design

FDA source

Sorin Group Deutschland GmbH began a recall of CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used with an Electrical Remote-Controlled (ERC) tubing... on 2017-10-30. FDA classified it as Class II and gives the reason as "Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after detection of an air bubble could take longer than is intended by design in the CP5 system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0401-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-30
Posted: 2018-01-19
Terminated: 2024-01-26
Recalling firm: LivaNova Deutschland GmbH
Product: CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used with an Electrical Remote-Controlled (ERC) tubing clamp and a bubble sensor.
Product code: DWA Control, Pump Speed, Cardiopulmonary Bypass
Reason for recall: Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after detection of an air bubble could take longer than is intended by design in the CP5 system.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were notified of the recall via USPS trackable mail, beginning on 10/30/2017. The letter informed customers Instructions included to continue following the Instructions for use, including use of an arterial filter on the arterial line, and that a LivaNova representative will contact them to schedule an upgrade to their device.
Quantity in commerce: 1,318 units
Distribution: Distributed domestically to Distributed internationally to Algeria, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Ecuador, Estonia, Finland, France, Germany, Hong Kong, Iraq, Italy, Japan, Jordan, Kuwait, Libya, Lithuania, Luxembourg, Malaysia, Morocco, Norway, Palestinian Territory, Panama, Peru, Poland, Qatar, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, The Netherlands, Tunisia, United Kingdom, Vietnam
Product codes and lots: Model No. 60-00-60. Drive Unit: Ref #60-01-04, UDI 04033817900948. Emergency System: Ref #60-01-35, UDI 04033817900955. Pump Control Panel: Ref #60-02-60, UDI 04033817901006.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0401-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0401-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-31	2018-01-19

Product code DWA

K112225Class IISorin Centrifugal Pump 5 (Cp5)Sorin Group Deutschland GmbH / cleared 2011-09-20

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)