RegWardenFDA facility compliance records
Facility

LivaNova Deutschland GmbH

4 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2019: 1 recalls; 2021: 1 recalls; 2022: 1 inspections; 2023: 1 recalls; 2024: 1 recalls201720181201920201202112022120231202420252026
  • Recalls (4)
  • Inspections (1)

Devices registered here (1)

  • Console, Heart-Lung Machine, Cardiopulmonary Bypass
    Product code DTQ (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.4220

Recalls & enforcement

  • Class IIOngoing2024-10-18
    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…
  • Class IIOngoing2023-08-03
    The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.
  • Class IIITerminated2021-12-17
    One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
  • Class IITerminated2019-08-26
    The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrifugal pump during cardiopulmonary bypass may be difficult or impossible to rotate as a result of premature wear of the angle encoder. The loss of function of the angle en…

FDA inspections (1)

  • VAI2022-04-28
    Voluntary Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “LivaNova Deutschland GmbH (FEI 3002808267) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002808267-livanova-deutschland-gmbh/

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