Drug recall
Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for…
FDA recall event 86907 · Class II · Medtronic Neuromodulation
Key facts
| Event ID | 86907 |
|---|---|
| Recall numbers | Z-0612-2021 |
| Recalling firm | Medtronic Neuromodulation |
| Product type | Devices |
| Products | Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device. |
| Initiation date | Nov 19, 2020 |
| Report date | Dec 23, 2020 |
| Termination date | Apr 3, 2023 |
| City | Minneapolis |
| State | MN |
| Country | United States |
| FEI number | 2182207 |
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: