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LivaNova Deutschland GmbH FDA Inspection Record

FEI 3002808267 · Inspections, Form 483s, warning letters and import refusals

LivaNova Deutschland GmbH is an FDA-registered facility (FEI 3002808267) located in MUNCHEN Bavaria, DE. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Apr 28, 2022: Voluntary Action Indicated (VAI)
Inspections on record
2 (1 OAI, 1 VAI)
Last OAI inspection
Apr 13, 2011
Warning letters
1 listed by FDA for this FEI, latest Aug 2, 2011
Recalls as the recalling firm
7, latest Oct 18, 2024
Import refusals
1

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Apr 28, 2022Voluntary Action Indicated (VAI)Design validation- Lack of or inadequate procedures (21 CFR 820.30(g))
Investigation of device failures (21 CFR 820.198(c))
Lack of or inadequate process validation (21 CFR 820.75(a))
Apr 13, 2011Official Action Indicated (OAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Oct 18, 2024Class IIZ-0571-2025Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control…
Aug 3, 2023Class IIZ-0073-20243T Heater Cooler System, REF: 16-02-85
The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.
Dec 17, 2021Class IIIZ-0787-2022Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI…
One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
Aug 26, 2019Class IIZ-2439-2020Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2… and 1 more product
The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrifugal pump during…
Oct 30, 2017Class IIZ-0401-2018CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control…
Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after detection of an air bubble could take…
Dec 4, 2013Class IIZ-0856-2014S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended… and 1 more product
Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob…
Sep 24, 2013Class IIZ-0142-2014S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert…
Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.

FDA record score

10 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

9 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIApr 28, 20226 x 0.63.6
Class II recall Z-0571-2025, this FEI as the recalling firmOct 18, 20244 x 0.62.4
Class II recall Z-0073-2024, this FEI as the recalling firmAug 3, 20234 x 0.62.4
Class II recall Z-2439-2020, this FEI as the recalling firmAug 26, 20194 x 0.251
Class II recall Z-0401-2018, this FEI as the recalling firmOct 30, 20174 x 0.251
Class II recall Z-0856-2014, this FEI as the recalling firmDec 4, 201310 years or older, so it adds no points0
Class II recall Z-0142-2014, this FEI as the recalling firmSep 24, 201310 years or older, so it adds no points0
Warning letter on FDA's dashboard, which does not show close-outsAug 2, 201110 years or older, so it adds no points0
Inspection classified OAIApr 13, 201110 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
LivaNova Deutschland GmbH
Location
MUNCHEN Bavaria (DE)
Source
device

Compliance actions

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.