Drug recall
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in…
FDA recall event 89470 · Class I · ev3 Inc.
Key facts
| Event ID | 89470 |
|---|---|
| Recall numbers | Z-0694-2022, Z-0695-2022 |
| Recalling firm | ev3 Inc. |
| Product type | Devices |
| Products | Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature., Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature. |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization. |
| Initiation date | Feb 4, 2022 |
| Report date | Mar 16, 2022 |
| Termination date | Oct 2, 2024 |
| 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: