The FDA announced a class I recall of the Medtronic Hawk One directional atherectomy catheter system due to more than 160 reports of problems with the device’s guidewire. The catheter tip could break ...
The US Food and Drug Administration (FDA) said today that Medtronic is recalling its HawkOne Directional Atherectomy System due to reports of the guidewire prolapsing when force is applied, which can ...
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Medtronic has recalled the TurboHawk Plus directional atherectomy system, used in the peripheral arteries, due to the risk of catheter-tip damage during use, the US Food and Drug Administration ...
Medtronic and the FDA are expanding the reach of a Class I recall handed down in January for the medtech giant’s catheter designed to clear out clogged arteries. The previous recall covered more than ...
DUBLIN - Oct. 24, 2016 - Medtronic plc (MDT) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the HawkOne(TM) Directional Atherectomy System in a new size for treating ...
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