Manufacturer
43 recalls in our database name LivaNova USA, Inc. as the manufacturing or recalling firm.
Of the 43 recalls from LivaNova USA, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (7%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
LivaNova USA Inc. is voluntarily recalling 220 units of 3/8 inch Y connectors due to a Class II defect.
LivaNova USA Inc. is recalling 420 units of sterile standalone connectors because internal tests identified potential breaches in the sterile barrier.
LivaNova USA Inc. is recalling 860 units of Sterile Standalone Connectors because internal tests identified a potential breach in the sterile barrier.
LivaNova USA Inc. is recalling 240 units of sterile standalone connectors because internal tests found potential breaches in the sterile barrier.
LivaNova USA Inc. is recalling 120 units of sterile disposable connectors because internal tests found the sterile barrier may be breached.
LivaNova is recalling 2,683 VNS Therapy Programmer Model 3000 units because a specific sequence of actions may trigger a false positive warning, potentially leading to unnecessary medical intervention.
LivaNova is recalling Heater-Cooler System 3T units to reduce the risk of NTM contamination by providing validated cleaning and disinfection instructions.
LivaNova USA Inc. is recalling 27 SMART PERFUSION PACK INSPIRE 8S units because they were packaged with the incorrect cuvette component.
LivaNova USA Inc is recalling six VNS Therapy SENTIVA Generator Model 1000 units because they were sterilized one additional cycle, failing to meet quality specifications.
LivaNova USA Inc. is recalling five Sorin Connect Datapad devices because they have incorrect manufacturing date labels. The devices were distributed in New Jersey and California.
LivaNova is recalling 745 Cyberonics VNS Therapy AspireSR Model 106 generators due to electrical leakage causing premature battery depletion.
LivaNova USA Inc is recalling 106 Cyberonics VNS Therapy AspireHC Model 105 generators due to electrical leakage causing premature battery depletion.
LivaNova is recalling SenTiva VNS Therapy generators that may reset and become disabled within 60 days of enabling, potentially requiring additional surgery or causing a return of symptoms.
LivaNova is recalling 643 VNS Therapy Program tablets due to a software error that causes incorrect diagnostic tests on specific devices.
LivaNova is recalling VNS Therapy System generators because a timing change causes reported lead impedance values to be higher than previous models, shifting normal ranges relative to existing thresholds.
LivaNova USA Inc. is recalling SORIN Heater-Cooler System 3T units because a chemical reaction may render the water preservative ineffective, potentially allowing micro-organism growth.
LivaNova USA Inc. is recalling six Sorin Heater-Cooler System 3T units because post-cleaning water samples tested positive for nontuberculous mycobacteria.
LivaNova is recalling 243 VNS Therapy Programming Systems because they may display unintended warning messages. The devices were distributed to 16 U.S. states.
Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.
LivaNova
UK business
Source: Wikidata (Q21592516), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.