Recall Z-0787-2022 ยท DWA Control, Pump Speed, Cardiopulmonary Bypass
LivaNova Deutschland GmbH
Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device.
| Date | Dec 17, 2021 |
| Status | Terminated |
| Reason | One ferrite ring expected to be installed on centrifugal pump system power cable may not be present. |
| Root cause | Process control |
| Action | On 12/17/2021, the firm notified affected customers via email using a letter titled, "URGENT MEDICAL DEVICE CORRECTION FA-CP-MUN-2021-001." The letter indicated the following actions to be taken by the customer: Using the attached Customer Response Form (Attachment 1), please respond by email to LivaNova.FSCA@livanova.com to confirm the receipt of this letter and that you have read and understood its content. No further action is requested. A LivaNova authorized technician will contact you to schedule an appointment and correct the devices with the missing ferrite ring. Any affected device |
| Quantity | 4 |
| Distribution | US distribution in states of FL, TX, and NE |
| 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 |