Z-1389-2020Class III

LivaNova SMART PERFUSION PACK INSPIRE 8S -

Name: Z-1389-2020 LivaNova SMART PERFUSION PACK INSPIRE 8S -
Creator: LivaNova USA Inc.
Published: 2019-07-03
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2019-07-03 / Terminated / root cause: manufacturing process

FDA source

LivaNova USA Inc. began a recall of LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal... on 2019-07-03. FDA classified it as Class III and gives the reason as "Perfusion tubing pack was packaged with the incorrect cuvette". 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-1389-2020
Classification: Class III
Status: Terminated
Initiated: 2019-07-03
Posted: 2020-02-27
Terminated: 2021-07-09
Recalling firm: LivaNova USA, Inc.
Product: LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood.
Product code: DWE Tubing, Pump, Cardiopulmonary Bypass
Reason for recall: Perfusion tubing pack was packaged with the incorrect cuvette.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On 07/03/2019, the firm contact it customers in person and on 07/08/2019 sent a "MEDICAL DEVICE CORRECTION" Letter informing them of the incorrect cuvette was assembled into Perfusion Pack 046008200 (Lot Number 1912100141) and instructed the customers to: 1. Please check their inventory for PTS pack 046008200, with lot number 1912100141 delivered to their facility; 2. Using the attached Customer Response Form (Attachment 1), please respond by email to [email protected] to confirm that they have affected products in their facility; 3. All PTS pack 046008200 with lot number 1912100141 should not be used and should be returned. The Recalling Firm will be contacting its customers to organize the replacement of the affected products. 4. Ensure that this Medical Device Correction is communicated to all personnel within their organization who need to be aware of it. If the customer has 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]. For questions regarding this Medical Device Correction, please contact us at (800) 986-4702 or by e-mail to [email protected].
Quantity in commerce: 27 packs
Distribution: US Nationwide distribution in the state of IL.
Product codes and lots: Model Number: 046008200 Lot Number: 1912100141 UDI: (01)00803622140136(240)046008200 (17)210430(10)1912100141 Cuvette Component P/N 03016 - SAT/HCT B-care 5 cuvette

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1389-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1389-2020	Class III	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-27

Product code DWE

K981613Class IICobe Smarxt Tubing and ConnectorsCobe Cardiovascular, Inc. / cleared 1998-10-26

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)