Drug recall
Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in…
FDA recall event 78570 · Class II · Medtronic Inc.
Key facts
| Event ID | 78570 |
|---|---|
| Recall numbers | Z-0188-2018 |
| Recalling firm | Medtronic Inc. |
| Product type | Devices |
| Products | Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Stent length on the label may not match the length of the stent itself. |
| Initiation date | Nov 3, 2017 |
| Report date | Dec 6, 2017 |
| Termination date | Sep 1, 2020 |
| City | Plymouth |
| State | MN |
| Country | United States |
| FEI number | 2183870 |
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: