Recall Z-0401-2018 ยท DWA Control, Pump Speed, Cardiopulmonary Bypass
Sorin Group Deutschland GmbH
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.
| Date | Oct 30, 2017 |
| Status | Terminated |
| Reason | 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 | 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 | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112225 | SORIN CENTRIFUGAL PUMP 5 (CP5) Sorin Group Deutschland GmbH, Sep 20, 2011 |