Z-0787-2022Class III

Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM...

Name: Z-0787-2022 Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM...
Creator: LivaNova Deutschland GmbH
Published: 2021-12-17
License: https://open.fda.gov/license/

LivaNova Deutschland GmbH / initiated 2021-12-17 / Terminated / root cause: manufacturing process

FDA source

LivaNova Deutschland GmbH began a recall of Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary... on 2021-12-17. FDA classified it as Class III and gives the reason as "One ferrite ring expected to be installed on centrifugal pump system power cable may not be present". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0787-2022
Classification: Class III
Status: Terminated
Initiated: 2021-12-17
Posted: 2022-03-15
Terminated: 2024-01-08
Recalling firm: LivaNova Deutschland GmbH
Product: 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.
Product code: DWA Control, Pump Speed, Cardiopulmonary Bypass
Reason for recall: One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
Root cause tag: manufacturing process
FDA 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 [email protected] 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 currently in use may continue to be used without limitation. For questions regarding this Medical Device Correction, please contact a LivaNova sales rep or send an e-mail LivaNova Quality Assurance Team at [email protected]. Please, complete this response form and return it via e-mail to [email protected] no later than December 31st, 2021.
Quantity in commerce: 4
Distribution: US distribution in states of FL, TX, and NE
Product codes and lots: CP5 Drive Unit Serial Numbers: 60E03336 60E03339 60E03344 60E03347

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0787-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0787-2022	Class III	Terminated	Voluntary: Firm initiated	2022-03-23	2022-03-15

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)