LivaNova USA Inc VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.
Brand
LivaNova USA Inc
Lot Codes / Batch Numbers
Model 3000 version 1.6
Products Sold
Model 3000 version 1.6
LivaNova USA Inc is recalling VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generato due to False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current,. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current, 3) In-session re-interrogation performed. Users instructed to lower output current and widen pulse width. Only system diagnostic testing evaluates output current. Users may conclude device malfunction, could lead to medical/surgical intervention.
Recommended Action
Per FDA guidance
On 02/04/20, Urgent Medical Device Correction notices were mailed to Doctors, who were informed the following: Which Patients are Potentially Impacted? Because the false positive warning message only appears if the generator is initially interrogated at 0mA, there are only certain scenarios where the issue may appear: - After initial implant, when the device is programmed on for the first time; - Following an MRI, after the device was programmed to 0mA per labeling instructions; or - Resuming therapy following previous device disablement due to an adverse event or device issue. Actions to be taken by the Physician: 1. If you obtain the low output current warning message, follow the Physician's Manual instructions to perform a System Diagnostics test after initial interrogation and programming before utilizing in-session re-interrogation. 2. During programming visits, always perform System Diagnostics testing immediately after any programming operations are performed to ensure the device is delivering programmed stimulation as intended. 2. Please complete and return the attached Customer Response Form. Please ensure that this notice is communicated to all personnel within your organization who need to be aware of it. To report a complaint or for technical support, contact the Customer Quality team at cservices@livanova.com or (866) 882-8804. Actions to be taken by Company: An update to the software is in development to eliminate this false positive low output current message. Information on availability of the software update will be shared in future communications. New users will be trained on proper use of programming system, including the appropriate sequence of use of diagnostic testing.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC
Page updated: Jan 10, 2026