Z-1563-2020Class II

VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators

Name: Z-1563-2020 VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators
Creator: LivaNova USA Inc
Published: 2020-02-04
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2020-02-04 / Open, Classified / root cause: software

FDA source

LivaNova USA Inc began a recall of VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators on 2020-02-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1563-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-02-04
Posted: 2020-03-24
Recalling firm: LivaNova USA, Inc.
Product: VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.
Product code: LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software Design Change
Action: 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 [email protected] 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.
Quantity in commerce: 2683
Distribution: U.S.: LA, ID, AZ, UT, KY, VA, TN, NY, SC, IL, IN, NC, WA, CA, OH, FL, PA, NJ, CO, TX, RI, MD, HI, OR, MA, NE, MO, OK, MS, MN, SD, VT, AR, WV, WI, MI, AL, KS, DE, NM, GA, ND, AK, MT, ME, NV, DC, MO, WY, IA, CT. Canada, and Israel.
Product codes and lots: Model 3000 version 1.6

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1563-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1563-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-01	2020-03-24

Product code LYJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)