CP5 recallZ-0401-2018 · Sorin Group Deutschland GmbH · initiated Oct 30, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Sorin Group Deutschland GmbH or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0401-2018
- Status
- Terminated
- Initiated by the company
- Oct 30, 2017
- Recalling firm
- Sorin Group Deutschland GmbH
- Quantity
- 1,318 units
- Product code
- DWA
- FDA submissions
- K112225
- 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 description
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.
Code information (models, lots, serial numbers)
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.
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- CP5 Pump Control PanelLivaNova Deutschland GmbH · Control, pump speed, cardiopulmonary bypass1 recall53 reports
- CP5 Drive UnitLivaNova Deutschland GmbH · Control, pump speed, cardiopulmonary bypass1 recall32 reports
- CP5 Emergency SystemLivaNova Deutschland GmbH · Control, pump speed, cardiopulmonary bypass1 recall2 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K112225 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- CP5 Pump Control PanelLivaNova Deutschland GmbH · Control, pump speed, cardiopulmonary bypass9 reports
- Flow Measurement Sensor ModuleLivaNova Deutschland GmbH · Control, pump speed, cardiopulmonary bypass1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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