FDA Device recall Z-1563-2020
VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators
- FDA Device
- Class II
- ongoing
- Published 2020-04-01
On 2020-04-01 the FDA classified a Class II recall of VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators by Livanova Usa, citing 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-interrogati….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1563-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-02-04 |
| Published | 2020-04-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Livanova Usa |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.
Reason
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.
Identifiers
| code_info | Model 3000 version 1.6 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1563-2020%22
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