Z-1119-2020Class III

LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594

Name: Z-1119-2020 LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594
Creator: LivaNova USA Inc.
Published: 2019-01-28
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2019-01-28 / Terminated / root cause: labeling and UDI

FDA source

LivaNova USA Inc. began a recall of LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to perform, control... on 2019-01-28. FDA classified it as Class III and gives the reason as "Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Specifically the manufacturing date in the production identifier was incorrect and the manufacturing date on the unique device...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1119-2020
Classification: Class III
Status: Terminated
Initiated: 2019-01-28
Posted: 2020-02-10
Terminated: 2022-01-31
Recalling firm: LivaNova USA, Inc.
Product: LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Specifically the manufacturing date in the production identifier was incorrect and the manufacturing date on the unique device identifier label was labeled in the format of yy-mm-dd instead of yyyy-mm-dd.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On 01/28/2019, a Medical Device Correction letter was mailed to affected consignees. The letter asked customers to take the following actions: 1. Please check your inventory using the list of affected products delivered to your facility in Attachment 1; 2. Using the attached Customer Response Form (Attachment 2), please respond by email to [email protected] to confirm that you have affected products in your facility. Your LivaNova reference person will contact you for the replacement of the product labels with labels bearing the correct manufacturing date. 3. Please ensure that this Medical Device Correction is communicated to all personnel within your organization who need to be aware of it. If you have transferred any of the affected devices to a third party, please communicate this information to them and inform the LivaNova Quality Assurance Team at [email protected]. 4. For questions regarding this Medical Device Correction, please contact us at (800) 986-4702 or by e-mail to [email protected].
Quantity in commerce: 5 Datapads
Distribution: US: NJ and CA
Product codes and lots: Device Model, Catalog Number, Serial Number: SORIN CONNECT DPIII KOMPL. S5, 24-90-80, 17BQC0247 SORIN CONNECT DPIII KOMPL. S5, 24-90-80, 17BQC0249 SORIN CONNECT DPIII KOMPL. S5, 24-90-80, 17BQC0250 SORIN CONNECT DPIII KOMPL. S5, 24-90-80, 17BQC0258 DATAPADIII WITHOUT SOFTWARE, 24-90-87, 17BQC0257

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1119-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1119-2020	Class III	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-10

Product code DTQ

K071318Class IIModification to: Stockert S5 SystemSorin Group Deutschland GmbH / cleared 2007-07-06

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)