ev3 Inc.: 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.

Agency Publication Date: March 7, 2022

Affected Products

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

GTIN 00763000402396

Product: Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.

GTIN 00763000402419

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89470

Status: Resolved

Manufacturer: ev3 Inc.

Manufactured In: United States

Units Affected: 2 products (441 devices; 245 devices)

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Sources: FDA iRES · Raw API Response

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Critical RiskFDA Device