Medtronic TurboHawk Plus Directional Atherectomy System Recalled Due to Design Defect
ev3 Inc. is recalling the Medtronic TurboHawk Plus Directional Atherectomy System due to design similarities to a device with reported tip detachment and embolization incidents. The FDA has classified this as a Class I recall.
- Product
- Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.
- Category
- Medical Device
- Distribution
- Distributed nationwide