Every recall we track for LivaNova USA, Inc. — 43 in all — plus the complaints and injury reports the public filed about them.
LivaNova recalls SenTiva DUO VNS Therapy generators (Model 1000-D) that may stop delivering nerve stimulation therapy due to internal component issues. Affected units were sold starting May 13, 2020.
LivaNova USA, Inc. is a leading medical device manufacturer specializing in innovative solutions for cardiovascular and respiratory care. We provide advanced technologies to improve patient outcomes and quality of life.
LivaNova recalls SenTiva VNS generators (serial numbers <500,000) that may stop delivering nerve stimulation, risking seizure return or surgery. Affected users should contact for replacement.
LivaNova recalls SenTiva and SenTiva Duo vagus nerve stimulator generators with serial numbers under 500,000 that may stop delivering therapy, risking seizure return or surgery.
LivaNova recalls VNS therapy leads model 303 due to potential silicone tubing wall thickness issues that could cause lead breach and discomfort or loss of therapy.
LivaNova recalls SENTIVA DUO device model 1000-D with serial numbers 311298, 310443, 310068, 310353, 310531, 310351, 310380, 310348 due to incorrect model number display after reset.
LivaNova recalls certain VNS Therapy AspireSR Generator devices with serial numbers containing an extra digit that may not work with software version 11.0.4. Affected units can be identified by specific serial numbers listed in the recall notice.
LivaNova recalls sterile vein irrigation cannulas with blunt tips due to potential sterile barrier breaches in specific packaging. Affected units have a GTIN 00803622133091 and were produced in Lot 2004900018.
LivaNova recalls certain Sterile Disposable Connectors due to potential sterile barrier breaches in specific production batches. Affected units may have compromised packaging that could risk contamination during medical procedures.
LivaNova recalls certain Sterile Disposable Connectors due to potential sterile barrier breaches in specific production lots. Affected units may have compromised packaging that could lead to contamination risks during medical use.
LivaNova recalls sterile disposable connectors with specific GTIN and lot numbers due to potential sterile barrier breaches in certain production batches.
LivaNova recalls certain Sterile Disposable Connectors due to potential sterile barrier breaches in specific production lots. Affected units may have compromised packaging that could lead to contamination risks during medical procedures.
LivaNova recalls specific sterile standalone connectors due to potential sterile barrier breaches in certain production lots. Affected units may have packaging issues that compromise sterility.
LivaNova recalls sterile disposable connectors with specific GTIN and lot numbers due to potential sterile barrier breaches. Affected units may have compromised packaging.
LivaNova recalls sterile disposable connectors with specific model and lot numbers due to potential barrier breaches in packaging. Affected units may have compromised sterility during use.
LivaNova recalls certain sterile standalone connectors (model EC2145S) due to potential sterile barrier breach in specific production lots. Affected units may have compromised packaging.
LivaNova recalls certain Sterile Disposable Connectors due to potential sterile barrier breaches in specific production lots. Affected units may have compromised packaging that could lead to contamination risks during medical procedures.
LivaNova recalls sterile disposable connectors with specific GTIN and lot numbers due to potential barrier breaches in packaging. Affected units may have compromised sterility.
LivaNova recalls specific sterile disposable connectors due to potential barrier breaches in certain production batches. Affected units may have packaging issues that could compromise sterility during use.
LivaNova recalls specific sterile standalone connectors (model EC2130S, lot 2004300009) due to potential sterile barrier breaches in certain packaging. Affected units may have compromised sterility.
LivaNova recalls specific sterile connectors due to potential sterile barrier breaches in certain production lots. Affected units may have packaging issues that compromise sterility during medical procedures.
LivaNova recalls specific 3/8X3/ 8X3/8 Y connectors due to fire risk. Affected units have EC2105S/ 00803622129285 labels. Stop using immediately to prevent fire.
LivaNova recalls specific sterile disposable connectors due to potential barrier breaches in certain production batches. Affected units may have packaging issues that could compromise sterility during medical use.
LivaNova recalls sterile disposable connectors with specific GTIN and lot numbers due to potential barrier breaches in packaging. Affected units may have compromised sterility.
LivaNova recalls certain sterile disposable connectors due to potential sterile barrier breaches in specific production lots. Affected units may have compromised packaging that could lead to contamination risks during medical use.
LivaNova recalls sterile disposable connectors with specific GTIN and lot numbers due to potential sterile barrier breaches. Affected units may have compromised packaging.
LivaNova recalls certain Sterile Disposable Connectors due to potential sterile barrier breaches in specific production lots. Affected units may pose infection risks during medical procedures. Consumers should check product labels for the lot number 2003400086.
LivaNova recalls sterile vein irrigation cannulas with blunt tips due to potential sterile barrier breaches in specific packaging. Affected units have a unique GTIN and lot number. Consumers should check their product labels for the recall details.
LivaNova recalls sterile disposable connectors with specific lot numbers due to potential barrier breaches in packaging. Affected units may have compromised sterility during use.
LivaNova recalls Heater-Cooler 3T systems for potential NTM contamination during cardiopulmonary bypass procedures. Follow cleaning instructions to reduce risk.
LivaNova recalls VNS Therapy Programmer Model 3000 (v1.6) used with specific VNS generators due to false positive warnings that may cause unnecessary medical procedures. Affected users should contact LivaNova for guidance.
LivaNova recalls sterile disposable connectors with a 3/8x1/4 reducer instead of 1/2x1/2. No health risk expected as the mismatched size prevents use.
LivaNova recalls SenTiva VNS therapy devices with serial numbers >= 100000 that may reset within 60 days, potentially requiring surgery or worsening symptoms.
LivaNova recalls VNS Therapy SENTIVA Generator Model 1000 units that were sterilized with an extra cycle, which may not meet quality standards. Affected units have specific model labels and serial numbers.
LivaNova recalls SMART PERFUSION PACK INSPIRE 8S tubing packs with incorrect cuvette packaging. Affected units have model 046008200 and lot 19121:100141. No remedy specified in recall notice.
LivaNova recalls S5 systems with incorrect manufacturing date labels. Some devices show dates in yy-mm-dd format instead of yyyy-mm-dd. Affected units may have labeling errors that could cause confusion during use.
Cyberonics recalls specific VNS Therapy AspireHC Model 105 generators due to premature battery depletion from electrical leakage. Affected units have serial numbers 35794-39731 and were sold between February 2017 and May 2017.
Cyberonics recalls VNS Therapy AspireSR Model 106 generators with serial numbers 36519-43201 due to premature battery depletion from electrical leakage in circuit boards.
LivaNova recalls VNS Therapy System generators with serial numbers less than 100,000 due to higher impedance readings during diagnostics, potentially causing incorrect settings. Affected users should contact for guidance.
LivaNova recalls VNS Therapy Program GMDN 3000 V1.5.2 software version devices that may display false high impedance values during patient follow-up due to a diagnostic test error.
LivaNova recalls SORIN Heater-Cooler System 3T models with potential disinfectant inefficiency and aerosol emission risks. Affected units may need repair or replacement to ensure patient safety during medical procedures.
LivaNova recalls six units of SORIN Heater-Cooler System 3T (REF 16-02-85) due to post-deep cleaning water testing positive for nontuberculous mycobacteria. Affected units have specific serial numbers.
LivaNova recalls VNS Therapy Programming System Model 3000 v1.0.2.2 due to unintended warning messages displayed on generators. Affected units have specific serial numbers and part numbers. No remedy is stated in the recall notice.
