FDAFebruary 24, 2020device
LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.
What to do
FDA enforcement status: Terminated
Brands named
livanova
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABrand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external prog...2025-01-03
- FDABrand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming syst...2025-01-03
- FDASenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).2024-12-12
- FDASenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).2024-12-12
- FDAEssenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software2024-10-18
- FDA3T Heater Cooler System, REF: 16-02-852023-08-03
- FDASorin 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.2021-12-17
- FDAVagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 303-30 PereniaDURA Lead (3.0 mm electrode inner diameter)2021-12-02
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