CLASS III Device recall · Reported 4 Mar 2020 · FDA Enforcement Report

LivaNova Smart Perfusion Pack Inspire 8S recalled

LivaNova USA is recalling LivaNova Smart Perfusion Pack Inspire 8S, distributed nationwide in the US. The recall was initiated on 3 Jul 2019 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesModel 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

Quantity recalled27 packs

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1389-2020
FDA event ID: 84732
Recalling firm: LivaNova USA, Arvada, CO
Classification: Class III
Status: Terminated
Recall initiated: 3 Jul 2019
FDA classified: 27 Feb 2020
Reported: 4 Mar 2020
Type: Voluntary: Firm initiated
Customers notified by: Visit
Reason category: Packaging Defects
Device type: Surgical Instruments

Timeline

3 Jul 2019	Recall initiated by company
27 Feb 2020	Classified by FDA	+239 days
4 Mar 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Perfusion tubing pack was packaged with the incorrect cuvette.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide distribution in the state of IL.

Nationwide Illinois

Questions about this recall

Is LivaNova Smart Perfusion Pack Inspire 8S recalled?

Yes. LivaNova USA recalled LivaNova Smart Perfusion Pack Inspire 8S on 3 Jul 2019. The recall is Class III and its status is Terminated. Recall number Z-1389-2020.

Why was it recalled?

Perfusion tubing pack was packaged with the incorrect cuvette.

Which lots are affected?

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

Where was it sold?

US Nationwide distribution in the state of IL.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from LivaNova USA

All 42

Reported	Class	Recall	Company	Reason	Where
12 Feb 2025Device	CLASS II	SenTiva, REF: 1000C, Generators Part of the VNS Therapy System recalled	LivaNova USA	Other	41 states
12 Feb 2025Device	CLASS II	SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part recalled	LivaNova USA	Other	41 states
5 Feb 2025Device	CLASS II	VNS Therapy¿ SenTiva DUO" recalled by LivaNova USA	LivaNova USA	Lead & Heavy Metals	Nationwide
9 Feb 2022Device	CLASS II	Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA recalled	LivaNova USA	Lead & Heavy Metals	7 states
16 Dec 2020Device	CLASS II	VNS Therapy Sentiva DUO # 1000-D recalled by LivaNova USA	LivaNova USA	Other	Nationwide

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