CLASS II ONGOING Device recall · Reported 18 Oct 2023 · FDA Enforcement Report

3T Heater Cooler System recalled by LivaNova Deutschland

LivaNova Deutschl is recalling 3T Heater Cooler System, distributed nationwide in the US. The recall was initiated on 3 Aug 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: (01)04033817900528/ Serial Numbers: 20T31334, 20T31336, 20T31366, 20T31391, 20T31375, 20T31322, 20T31348, 20T31345, 20T31362, 20T31363, 20T31364, 20T31407, 20T31531, 20T31532, 20T31534, 20T31367, 20T31368, 20T31369, 20T31370, 20T31371, 20T31372, 20T31373, 20T31386, 20T31387, 20T31388, 20T31389, 20T31390, 20T31550, 20T31551, 20T31552, 20T31553, 20T31543, 20T31544, 20T31536, 20T31346, 20T31347, 20T31361, 20T31365

Quantity recalled37 systems

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-0073-2024
FDA event ID: 92882
Recalling firm: LivaNova Deutschl, Munich, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 3 Aug 2023
FDA classified: 6 Oct 2023
Reported: 18 Oct 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

3 Aug 2023	Recall initiated by company
6 Oct 2023	Classified by FDA	+64 days
18 Oct 2023	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

The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.

Product as listed by the FDA

3T Heater Cooler System, REF: 16-02-85

Where it was distributed

US Nationwide distribution in the states of CA, IN, GA, NC, TX, AZ, FL, MN, NJ, CO, SC.

Nationwide Arizona California Colorado Florida Georgia Indiana Minnesota North Carolina New Jersey South Carolina Texas

Questions about this recall

Why was it recalled?

The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.

Which lots are affected?

UDI: (01)04033817900528/ Serial Numbers: 20T31334, 20T31336, 20T31366, 20T31391, 20T31375, 20T31322, 20T31348, 20T31345, 20T31362, 20T31363, 20T31364, 20T31407, 20T31531, 20T31532, 20T31534, 20T31367, 20T31368, 20T31369, 20T31370, 20T31371, 20T31372, 20T31373, 20T31386, 20T31387, 20T31388, 20T31389, 20T31390, 20T31550, 20T31551, 20T31552, 20T31553, 20T31543, 20T31544, 20T31536, 20T31346, 20T31347, 20T31361, 20T31365

Where was it sold?

US Nationwide distribution in the states of CA, IN, GA, NC, TX, AZ, FL, MN, NJ, CO, SC.

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 Deutschl

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8 Jul 2020Device	CLASS II	Control Panel recalled by LivaNova Deutschland	LivaNova Deutschl	Other	13 states
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