Perfusion Pack recallZ-1389-2020 · LivaNova USA Inc. · initiated Jul 3, 2019
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 LivaNova USA Inc. 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
Perfusion tubing pack was packaged with the incorrect cuvette.
FDA root cause category: Employee error
What the company is doing
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].
Recall details
- Recall number
- Z-1389-2020
- Status
- Terminated
- Initiated by the company
- Jul 3, 2019
- Recalling firm
- LivaNova USA Inc.
- Quantity
- 27 packs
- Product code
- DWE
- FDA submissions
- K981613
- Distribution
- US Nationwide distribution in the state of IL.
Product description
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.
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Perfusion PackLivanova USA, Inc.1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K981613 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ConnectorLivanova USA, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass5 reports
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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