CLASS II ONGOING Device recall · Reported 4 Dec 2024 · FDA Enforcement Report

Essenz HLM (Heart-Lung Machine) recalled by LivaNova Deutschland

LivaNova Deutschl is recalling Essenz HLM (Heart-Lung Machine), distributed nationwide in the US. The recall was initiated on 18 Oct 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 04033817903062. Software Version: 1.5. Serial Numbers: 49PK00436, 49PK00108, 49PK00374, 49PK00479, 49PK00480, 49PK00481, 49PK00093, 49PK00091, 49PK00092, 49PK00163, 49PK00497, 49PK00498, 49PK00219, 49PK00223, 49PK00224, 49PK00225, 49PK00226, 49PK00241, 49PK00255, 49PK00292, 49PK00291, 49PK00293, 49PK00490, 49PK00487, 49PK00488, 49PK00278, 49PK00274, 49PK00277, 49PK00275, 49PK00276, 49PK00273, 49PK00457, 49PK00458, 49PK00459, 49PK00455, 49PK00456, 49PK00290, 49PK00288

Quantity recalled38

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-0571-2025
FDA event ID: 95665
Recalling firm: LivaNova Deutschl, Munich
Classification: Class II
Status: Ongoing
Recall initiated: 18 Oct 2024
FDA classified: 27 Nov 2024
Reported: 4 Dec 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

18 Oct 2024	Recall initiated by company
27 Nov 2024	Classified by FDA	+40 days
4 Dec 2024	Published in enforcement report	+7 days

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

Reason for recall

Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to gas blender standby, then gas blender must be reactivated using user interface on blender, sensors deactivated until new case started; GUI reset can lead to Hypoxia and Hypoperfusion.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software

Where it was distributed

US Nationwide distribution in the states of CA, VA, GA, IN, NJ, FL, CO, MS, NV.

Nationwide California Colorado Florida Georgia Indiana Mississippi New Jersey Nevada Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI: 04033817903062. Software Version: 1.5. Serial Numbers: 49PK00436, 49PK00108, 49PK00374, 49PK00479, 49PK00480, 49PK00481, 49PK00093, 49PK00091, 49PK00092, 49PK00163, 49PK00497, 49PK00498, 49PK00219, 49PK00223, 49PK00224, 49PK00225, 49PK00226, 49PK00241, 49PK00255, 49PK00292, 49PK00291, 49PK00293, 49PK00490, 49PK00487, 49PK00488, 49PK00278, 49PK00274, 49PK00277, 49PK00275, 49PK00276, 49PK00273, 49PK00457, 49PK00458, 49PK00459, 49PK00455, 49PK00456, 49PK00290, 49PK00288

Where was it sold?

US Nationwide distribution in the states of CA, VA, GA, IN, NJ, FL, CO, MS, NV.

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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23 Mar 2022Device	CLASS III	Sorin Centrifugal Pump System, CP5, Drive Unit recalled	LivaNova Deutschl	Device Malfunction	FL, NE, TX
8 Jul 2020Device	CLASS II	Control Panel recalled by LivaNova Deutschland	LivaNova Deutschl	Other	13 states
8 Jul 2020Device	CLASS II	Control Panel recalled by LivaNova Deutschland	LivaNova Deutschl	Other	13 states

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