Device recall: VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600…

Class II FDA enforcement event 84710. Recall start date: 13 Aug 2019. Status in the FDA record: Terminated. Termination date: 18 May 2022.

Reason for recall, in the words of FDA

Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

LivaNova USA Inc started this device recall on 13 Aug 2019. The firm address in the FDA record is in Houston, TX. FDA put the recall in Class II. FDA event 84710 has 1 product record. The first FDA enforcement report date is 19 Feb 2020. The record gives the status Terminated, with the termination date 18 May 2022.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

US: FL, GA, KS, MO, and UT. No OUS distribution

Recalling firm

LivaNova USA Inc, Houston, TX.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 84710: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1118-2020	VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0000-5000 VNS Therapy System Physician s Manual (refer to Attachment 1)	6 generators	Class II	Terminated	19 Feb 2020

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2019: 968
Share of these events in Class II: 88%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 19

Other events of the firm

Other FDA enforcement events of 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

LivaNova USA Inc: all 19 events

Official channels

FDA enforcement report Z-1118-2020The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 84710. https://recallregister.com/fda/ii/84710/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US: FL, GA, KS, MO, and UT. No OUS distribution
What quantity of product is in FDA event 84710?: The FDA record gives this quantity: 6 generators
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2019 have the same class?: 88% of the 968 device events that started in 2019 are in Class II.