LivaNova VNS Therapy AspireSR Generator Recall for Serial Number Error
LivaNova is recalling 134 VNS Therapy AspireSR Generators because an extra digit in the serial number makes them incompatible with specific therapy programmers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a software compatibility issue rather than a direct physical injury risk, fitting the Moderate category for functional defects without reported harm.
Plain-English summary
LivaNova USA Inc is recalling 134 units of the VNS Therapy AspireSR Generator, an implantable pulse generator. The recall is due to a manufacturing error where an extra digit was inadvertently added to the serial number of a subset of the devices.
This serial number error causes the affected generators to be incompatible with therapy programmers running software version 11.0.4. The devices were distributed in 29 U.S. states and the District of Columbia, as well as in Argentina, Finland, and Peru.
Patients with these specific devices should contact their healthcare provider or LivaNova for instructions on how to proceed. The recall is limited to the specific serial numbers listed in the official FDA notice.
The recalled product
- Product
- VNS Therapy¿ AspireSR¿ Generator
- Manufacturer
- LivaNova USA Inc
- Affected units
- 134
Distribution
Related recalls
Same manufacturer · LivaNova USA Inc
See all →- HighVNS Therapy Generators May Stop Delivering Stimulation Due to Component Failure
FDA (Devices) · 2025-02-12
- HighVNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect
FDA (Devices) · 2025-02-12
- HighImplantable VNS Therapy Generators May Stop Delivering Treatment
FDA (Devices) · 2025-02-05
- HighImplantable Vagus Nerve Stimulation Device May Stop Delivering Therapy
FDA (Devices) · 2025-02-05
- HighVagus Nerve Stimulation Therapy Leads Recalled for Tubing Wall Defect
FDA (Devices) · 2022-02-09
Same hazard · software incompatibility
See all →- ModerateZ-800WF Infusion Pumps Recalled for Software Incompatibility Issue
FDA (Devices) · 2024-12-04
- ModerateMedtronic Restore Clinician Programmer software recalled for compatibility issue
FDA (Devices) · 2023-10-11
- ModerateA901 Communication Manager Software Update Not Available for Intellis System
FDA (Devices) · 2023-08-02
- ModerateHeartWare Ventricular Assist Device Monitor logfile processing failure
FDA (Devices) · 2023-06-28
- HighBD Pyxis MedBank Cabinet Software Update Prevents Drawer Access
FDA (Devices) · 2022-10-05
Similar recalls
- ModerateLivaNova Recalls Six VNS Therapy SENTIVA Generators for Sterilization Error
FDA (Devices) · 2020-02-19
- HighLivaNova Recalls Cyberonics VNS Therapy AspireSR Generators for Battery Depletion
FDA (Devices) · 2020-02-05
- ModerateLivaNova Recalls VNS Therapy SENTIVA DUO Generators Due to Model Number Error
FDA (Devices) · 2020-12-16
- ModerateLivaNova VNS Therapy System Recall Due to Impedance Measurement Shift
FDA (Devices) · 2019-11-13
- HighLivaNova VNS Therapy Programmer Recall Due to False Positive Warning Risk
FDA (Devices) · 2020-04-01
- HighImplantable VNS Therapy Generators May Stop Delivering Treatment
FDA (Devices) · 2025-02-05