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 95,110 HawkOne Directional Atherectomy Systems because of the risk of the guidewire within the catheter moving downward or prolapsing during use, which may damage the tip of the ...
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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 ...
The latest recall includes 686 devices in the U.S., distributed after the TurboHawk Plus received an FDA clearance in August 2021. (Medtronic) Medtronic and the FDA are expanding the reach of a Class ...
Medtronic has recalled 686 TurboHawk Plus Directional Atherectomy Systems because there is a risk that the guidewire within the catheter may move downward or prolapse during use, which may damage the ...
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