LivaNova Deutschland recalls

LivaNova Deutschland has 5 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 4 Dec 2024. 2 are still ongoing. The most frequent reason is lead & heavy metals.

Total recalls5since 2020

Last 12 months0reported

Class I00% of total

Ongoing2latest 4 Dec 2024

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 1 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 4 80%Class III 1 20%

Why livanova deutschland is recalled

Product types

Other Medical Devices480%
Medical Software120%

By year

2024120%
2023120%
2022120%
2020240%

Ongoing livanova deutschland recalls

2 active

Reported	Class	Recall	Company	Reason	Where
4 Dec 2024Device	CLASS II	Essenz HLM (Heart-Lung Machine) recalled by LivaNova Deutschland	LivaNova Deutschland	Lead & Heavy Metals	Nationwide
18 Oct 2023Device	CLASS II	3T Heater Cooler System recalled by LivaNova Deutschland	LivaNova Deutschland	Other	Nationwide

All livanova deutschland recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
4 Dec 2024Device	CLASS II	Essenz HLM (Heart-Lung Machine) recalled by LivaNova Deutschland	LivaNova Deutschland	Lead & Heavy Metals	Nationwide
18 Oct 2023Device	CLASS II	3T Heater Cooler System recalled by LivaNova Deutschland	LivaNova Deutschland	Other	Nationwide
23 Mar 2022Device	CLASS III	Sorin Centrifugal Pump System, CP5, Drive Unit recalled	LivaNova Deutschland	Device Malfunction	FL, NE, TX
8 Jul 2020Device	CLASS II	Control Panel recalled by LivaNova Deutschland	LivaNova Deutschland	Lead & Heavy Metals	13 states
8 Jul 2020Device	CLASS II	Control Panel recalled by LivaNova Deutschland	LivaNova Deutschland	Lead & Heavy Metals	13 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.