Drug recall
The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the…
FDA recall event 70271 · Class II · Medtronic Neuromodulation
Key facts
| Event ID | 70271 |
|---|---|
| Recall numbers | Z-1147-2015 |
| Recalling firm | Medtronic Neuromodulation |
| Product type | Devices |
| Products | The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, Peripheral Nervous System, or muscles when… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Current labeling indicates that cycling improves device longevity in every programming scenario. However, enabling cycling at certain parameter settings may decrease the device battery longevity. With… |
| Initiation date | Jan 9, 2015 |
| Report date | Mar 4, 2015 |
| Termination date | Sep 28, 2017 |
| City | Minneapolis |
| State | MN |
| Country | United States |
| FEI number | 3007566237 |
At a glance
- 1–9 Products in this recall
- None 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: