Munich, N/A, Germany
LivaNova Deutschland GmbH recalls
4 recalls recorded since 2018, most recently on 18 October 2024. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)2
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 18 October 2024
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of CA, VA, GA, IN, NJ, FL, CO, MS, NV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0571-2025
- Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
Ongoing Class II Medical devices
- Recall started
- 3 August 2023
- Reason
- The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.
- Distribution
- US Nationwide distribution in the states of CA, IN, GA, NC, TX, AZ, FL, MN, NJ, CO, SC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0073-2024
- 3T Heater Cooler System, REF: 16-02-85
Terminated Class III Medical devices
- Recall started
- 17 December 2021
- Terminated
- 8 January 2024
- Reason
- One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
- Distribution
- US distribution in states of FL, TX, and NE
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0787-2022
- Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device.
Terminated Class II Medical devices
- Recall started
- 26 August 2019
- Terminated
- 22 April 2021
- Reason
- 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 encoder during bypass may lead to ischemia, stroke, organ damage, arterial tissue injury or reperfusion syndrome.
- Distribution
- US: FL, GA, IN, KY, MI, MO, NY, OH, PA, SC, TN, TX, VA OUS: Canada - Uzbekistan - Turkey - Tunisia - Taiwan - South Africa - Serbia - Saudi Arabia - Russia - Poland - Mexico - Korea(Rep. of) - India - Hong Kong - Colombia - China - Brazil - Bahrain - Argentina - Algeria - Ita
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2440-2020, Z-2439-2020
- Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986
- Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.