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ev3 Inc FDA Recalls

5 recalls on file across devices, 4 of them Class I and 1 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AClass IIDec 10, 2024There is the potential for in-vivo balloon deflation issues,	There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the	Class IIDevices	Dec 10, 2024
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vClass IFeb 4, 2022The device has similarities in design to another device that	The device has similarities in design to another device that the firm recently issued a field correction on du	Class IDevices	Feb 4, 2022
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vaClass IFeb 4, 2022The device has similarities in design to another device that	The device has similarities in design to another device that the firm recently issued a field correction on du	Class IDevices	Feb 4, 2022
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) RecommenClass IDec 6, 2021Reports have been received of tip damage during use of the d	Reports have been received of tip damage during use of the devices which resulted in some instances of tip det	Class IDevices	Dec 6, 2021
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) RecommendClass IDec 6, 2021Reports have been received of tip damage during use of the d	Reports have been received of tip damage during use of the devices which resulted in some instances of tip det	Class IDevices	Dec 6, 2021

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