LivaNova USA recalls

LivaNova USA has 42 recalls on record with the FDA and USDA, the earliest in 2018 and the latest reported on 12 Feb 2025. 6 are still ongoing. The most frequent reason is sterility.

Total recalls42since 2018

Last 12 months0reported

Class I12% of total

Ongoing6latest 12 Feb 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 3 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 1 2%Class II 38 90%Class III 3 7%

Why livanova usa is recalled

Product types

By year

202537%
202212%
20203379%
2019410%
201812%

Ongoing livanova usa recalls

6 active

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
1 Apr 2020Device	CLASS II	VNS Therapy Programmer recalled by LivaNova USA	LivaNova USA	Lead & Heavy Metals	50 states
18 Dec 2019Device	CLASS II	VNS Therapy Program GMDN recalled by LivaNova USA	LivaNova USA	Device Malfunction	47 states
13 Nov 2019Device	CLASS II	The LivaNova VNS Therapy System, used recalled	LivaNova USA	Lead & Heavy Metals	50 states

All livanova usa recalls, newest first

42 total

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
25 Nov 2020Device	CLASS II	VNS Therapy¿ AspireSR¿ Generator recalled by LivaNova USA	LivaNova USA	Device Malfunction	29 states
29 Jul 2020Device	CLASS III	Sterile Disposable Connector recalled by LivaNova USA	LivaNova USA	Sterility	5 states
8 Jul 2020Device	CLASS II	Vein Irrigation Cannula with blunt tip recalled by LivaNova USA	LivaNova USA	Sterility	44 states
8 Jul 2020Device	CLASS II	Sterile Disposable Connectors ASY CONN Y 1///8 STR recalled	LivaNova USA	Sterility	44 states
8 Jul 2020Device	CLASS II	Sterile Disposable Connectors ASY 1//8 Reducer W/LL recalled	LivaNova USA	Sterility	44 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.