Drug recall
Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
FDA recall event 95489 · Class II · Medtronic Neuromodulation
Key facts
| Event ID | 95489 |
|---|---|
| Recall numbers | Z-0206-2025 |
| Recalling firm | Medtronic Neuromodulation |
| Product type | Devices |
| Products | Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device"… |
| Initiation date | Sep 24, 2024 |
| Report date | Oct 30, 2024 |
| 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: