Drug recall
Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and…
FDA recall event 96445 · Class II · Medtronic Neuromodulation
Key facts
| Event ID | 96445 |
|---|---|
| Recall numbers | Z-1543-2025 |
| Recalling firm | Medtronic Neuromodulation |
| Product type | Devices |
| Products | Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used. |
| Initiation date | Mar 4, 2025 |
| Report date | Apr 16, 2025 |
| 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: