medical Class I Updated 2022-03-16

ev3 Inc. recalls Medtronic TurboHawk Plus Directional Atherectomy System 6F,

Recalled Product

Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN 00763000402396
View official government recall

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