Drug recall
Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80…
FDA recall event 86872 · Class II · Medtronic Neuromodulation
Key facts
| Event ID | 86872 |
|---|---|
| Recall numbers | Z-0860-2021 |
| Recalling firm | Medtronic Neuromodulation |
| Product type | Devices |
| Products | Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device. |
| Initiation date | Nov 12, 2020 |
| Report date | Jan 20, 2021 |
| 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: