Drug recall
VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.
FDA recall event 84723 · Class II · LivaNova USA Inc
Key facts
| Event ID | 84723 |
|---|---|
| Recall numbers | Z-1563-2020 |
| Recalling firm | LivaNova USA Inc |
| Product type | Devices |
| Products | VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Feb 4, 2020 |
| Report date | Apr 1, 2020 |
| City | Houston |
| State | TX |
| Country | United States |
| FEI number | 1000117004 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: