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.

Perfusion tubing pack was packaged with the incorrect cuvette.

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].