CLASS II Device recall · Reported 16 Dec 2020 · FDA Enforcement Report

VNS Therapy Sentiva DUO # 1000-D recalled by LivaNova USA

LivaNova USA is recalling VNS Therapy Sentiva DUO # 1000-D. The recall was initiated on 12 Nov 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number - Model 1000-D Serial Numbers: 311298 310443 310068 310353 310531 310351 310380 310348

Quantity recalled8 generators

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-0535-2021
FDA event ID: 86776
Recalling firm: LivaNova USA, Houston, TX
Classification: Class II
Status: Terminated
Recall initiated: 12 Nov 2020
FDA classified: 4 Dec 2020
Reported: 16 Dec 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

12 Nov 2020	Recall initiated by company
4 Dec 2020	Classified by FDA	+22 days
16 Dec 2020	Published in enforcement report	+12 days

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

Reason for recall

During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.

Product as listed by the FDA

VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode.

Where it was distributed

International distribution in the countries of Austria and United Kingdom.

Questions about this recall

Why was it recalled?

During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.

Which lots are affected?

Model Number - Model 1000-D Serial Numbers: 311298 310443 310068 310353 310531 310351 310380 310348

Where was it sold?

International distribution in the countries of Austria and United Kingdom.

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 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 47

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	Packaging Defects	Nationwide
9 Feb 2022Device	CLASS II	Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA recalled	LivaNova USA	Device Malfunction	7 states
25 Nov 2020Device	CLASS II	VNS Therapy¿ AspireSR¿ Generator recalled by LivaNova USA	LivaNova USA	Device Malfunction	29 states

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