CLASS II Device recall · Reported 17 Apr 2019 · FDA Enforcement Report

Sorin Heater-Cooler System 3T recalled by LivaNova USA

LivaNova USA is recalling Sorin Heater-Cooler System 3T, distributed in Indiana, Missouri, Ohio. The recall was initiated on 14 Sep 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial numbers 16S13187, 16S14887, 16S15335, 16S15336, 16S15337, and 16S11877.

Quantity recalled6 devices

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-1099-2019
FDA event ID: 82365
Recalling firm: LivaNova USA, Arvada, CO
Classification: Class II
Status: Terminated
Recall initiated: 14 Sep 2018
FDA classified: 5 Apr 2019
Reported: 17 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Sterility
Device type: Other Medical Devices

Timeline

14 Sep 2018	Recall initiated by company
5 Apr 2019	Classified by FDA	+203 days
17 Apr 2019	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

For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.

Where it was distributed

US Distribution to states of: IN, MO, and OH.

Indiana Missouri Ohio

Questions about this recall

Is Sorin Heater-Cooler System 3T recalled?

Yes. LivaNova USA recalled Sorin Heater-Cooler System 3T on 14 Sep 2018. The recall is Class II and its status is Terminated. Recall number Z-1099-2019.

Why was it recalled?

For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).

Which lots are affected?

Serial numbers 16S13187, 16S14887, 16S15335, 16S15336, 16S15337, and 16S11877.

Where was it sold?

US Distribution to states of: IN, MO, and OH.

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 21 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 42

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

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