Food, drugs, devices › LivaNova USA Inc.

Device recall: LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgica

FDA enforcement event 84732 · Class III · initiated 3 Jul 2019 · status Terminated · terminated 9 Jul 2021

DeviceVoluntary: Firm initiated1 product recordArvada, CO

FDA enforcement event 84732 is a device recall by LivaNova USA Inc. of Arvada, CO, initiated 3 Jul 2019 and classified Class III, with 1 product record.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 6% of the 968 device enforcement events initiated in 2019 carry the same class.

Status: Terminated, terminated 9 Jul 2021. Initiation: voluntary: firm initiated. LivaNova USA Inc. has 19 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

LivaNova USA Inc., Arvada, CO.

Reason for recall

"Perfusion tubing pack was packaged with the incorrect cuvette."

Distribution

"US Nationwide distribution in the state of IL."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1389-2020	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.	27 packs	Class III	Terminated	4 Mar 2020

Context

6%of 2019 device events are Class III968 events that year

1product record in this eventfirm median: 1

19events on this register for the firm

Other enforcement events for LivaNova USA Inc.

Initiated	Product (first record)	Type	Class	Records
3 Jan 2025	Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Pro	Device	Class II	2
12 Dec 2024	SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulatio	Device	Class II	2
2 Dec 2021	Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode i	Device	Class II	1
12 Nov 2020	VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in pati	Device	Class II	1
28 Sep 2020	VNS Therapy¿ AspireSR¿ Generator	Device	Class II	1
24 Apr 2020	Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Insert Label:029165000/ 00803622123153	Device	Class II	22
24 Feb 2020	LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat ex	Device	Class II	1
4 Feb 2020	VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.	Device	Class II	1
18 Nov 2019	LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case	Device	Class III	1
22 Aug 2019	VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy	Device	Class I	1

All 19 events for LivaNova USA Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Perfusion tubing pack was packaged with the incorrect cuvette."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide distribution in the state of IL."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 9 Jul 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.