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LivaNova USA Inc

Complete recall history across all FDA and CPSC categories — 10 total recalls

LivaNova USA Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (10)

FDA medical device enforcement actions by LivaNova USA Inc

Date Product Reason Class
Nov 12, 2020 VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment... During internal testing, it was found that upon a device reset, the Generator... Class II
Sep 28, 2020 VNS Therapy¿ AspireSR¿ Generator Due to an extra digit being inadvertently added to the serial number of a sub... Class II
Feb 4, 2020 VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 81... False positive warning may occur after: 1) VNS Generator interrogated at 0mA ... Class II
Aug 22, 2019 VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal ne... Sentiva generators may reset and become disabled within 60 days of enabling. ... Class I
Aug 13, 2019 VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1... Firm identified a subset of its generators that were sterilized one additiona... Class II
Nov 16, 2018 Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The fir... This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiat... Class II
Nov 16, 2018 Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The fi... This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiat... Class II
Nov 16, 2018 The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), cons... Lead impedance values reported by the affected VNS generator will be higher c... Class II
Nov 16, 2018 VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly This recall is being initiated due to reports that that the therapy programmi... Class II
Jan 24, 2018 VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2 Unintended warning message displayed on generators programmed with a Model 30... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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