LivaNova USA Inc.: Medical Device Recall in 2020 - (Recall #: Z-1389-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: July 3, 2019

Date Posted: March 4, 2020

Recall Number: Z-1389-2020

Event ID: 84732

Reason for Recall:

Perfusion tubing pack was packaged with the incorrect cuvette.

Status: Terminated

Product Quantity: 27 packs

Code Information:

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

Distribution Pattern:

US Nationwide distribution in the state of IL.

Voluntary or Mandated:

Voluntary: Firm initiated