TCTMD

HawkOne Directional Atherectomy System Recalled Due to Risk of Tip Breakage

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 ...
Medscape

Medtronic Recalls HawkOne Directional Atherectomy System

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 ...
BioWorld

FDA reports recall of Medtronic Hawk One atherectomy device

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 ...
FierceBiotech

Medtronic, FDA expand HawkOne atherectomy recall to include TurboHawk Plus catheters

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 ...