Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The Recalled by LivaNova USA Inc. Due to Perfusion tubing pack was packaged with the incorrect...

Date: July 3, 2019
Company: LivaNova USA Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact LivaNova USA Inc. directly.

Affected Products

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.

Quantity: 27 packs

Why Was This Recalled?

Perfusion tubing pack was packaged with the incorrect cuvette.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About LivaNova USA Inc.

LivaNova USA Inc. has 28 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report