RegWardenFDA facility compliance records
Company

LivaNova Deutschland GmbH

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

Recalls by year

FDA actions on record by year2019: 1 recalls; 2021: 1 recalls; 2023: 1 recalls; 2024: 1 recalls20172018120192020120212022120231202420252026
  • Recalls (4)

Registered facilities (1)

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…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “LivaNova Deutschland GmbH — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-8010598-livanova-deutschland-gmbh/

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