LivaNova SMART PERFUSION PACK INSPIRE 8S: Incorrect Cuvette Packaging Risk

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Contact the company & request your remedy

Recalling firmLivaNova USA Inc.14401 W 65th Way, N/A · Arvada, CO 80004-3503

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

LivaNova is recalling SMART PERFUSION PACK INSPIRE 8S tubing packs that were packaged with the wrong cuvette. This could cause errors in blood monitoring during surgery. The recall affects specific model and lot numbers.

Why it’s dangerous

The perfusion tubing packs include the incorrect cuvette, which may lead to inaccurate blood monitoring during surgery. This could affect blood oxygen levels and other critical measurements. However, the recall does not specify immediate harm to users.

Who’s affected

Surgical teams using the LivaNova SMART PERFUSION PACK INSPIRE 8S during extracorporeal support procedures. Patients and staff at hospitals using the affected model and lot numbers are most at risk.

How to tell if you have this one

Check for model number 046008200 and lot number 1912100141 on the packaging. The UDI code (01)00803622140136(240)046008200(17)210430(10)1912100141 is also associated with the affected units.

Brand
LivaNova
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the model number (046008200) and lot number (1912100141) on the packaging.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The perfusion tubing packs were packaged with the incorrect cuvette, which could lead to inaccurate blood monitoring during surgery.

What is the model number for the affected product?

The model number is 046008200.

What lot number should I check for?

The lot number is 1912100141.

Take action

Contact LivaNova

We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1389-2020 — LivaNova LivaNova

Hello,

I own a LivaNova that is covered by recall Z-1389-2020 from LivaNova.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1389-2020 (July 3, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1389-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

LivaNova USA Inc. recalls LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in

Lower-risk recall