LivaNova Deutschland GmbH FDA Recalls

3 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with SoftwareClass IIOct 18, 2024Heart-Lung Machine GUI touchscreen may go dark for 10-15 sec	Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operatio	Class IIDevices	Oct 18, 2024
3T Heater Cooler System, REF: 16-02-85Class IIAug 3, 2023The firm's labeling (Quick Reference Guide) contains incorre	The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the	Class IIDevices	Aug 3, 2023
Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 SystClass IIIDec 17, 2021One ferrite ring expected to be installed on centrifugal pum	One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.	Class IIIDevices	Dec 17, 2021