ev3 Inc. recalls
2 recalls on record · 2 rated Critical · FDA
Every recall we have on record for ev3 Inc., compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
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Health Critical
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number…
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.
ev3 Inc. Mar 16, 2022
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Health Critical
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT.,…
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
ev3 Inc. Jan 26, 2022
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