Drug recall
VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels…
FDA recall event 84710 · Class II · LivaNova USA Inc
Key facts
| Event ID | 84710 |
|---|---|
| Recall numbers | Z-1118-2020 |
| Recalling firm | LivaNova USA Inc |
| Product type | Devices |
| Products | VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0000-5000… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications. |
| Initiation date | Aug 13, 2019 |
| Report date | Feb 19, 2020 |
| Termination date | May 18, 2022 |
| 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: