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.
FDA Recall Z-0401-2018 · Posted None
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Recalling FirmSorin Group Deutschland GmbH
Recall StatusTerminated
Product CodeDWA
Date Initiated2017-10-30
Date Terminated2024-01-26
Product Quantity1,318 units
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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