FDA Recalls Medtronic HawkOne Directional Atherectomy System Over Possible Blood Vessel Damage
The FDA issued a Class I recall of Medtronic HawkOne Directional Atherectomy System devices due to a serious risk to patient safety. The HawkOne Directional Atherectomy System is comprised of both a catheter which is threaded into the patient’s blood vessel and a cutter that is used to remove blockage from peripheral arteries and improve blood flow.
Over 160 complaints have been filed with the FDA reporting problems involving breakage of the devices including broken catheter tips and prolapsed guidewires that bulged outside of the catheter sheath. These device failures can lead to serious adverse events including torn or ruptured arteries, decreased blood flow due to a blocked artery, and other blood vessel complications that could require corrective surgery.
If you or someone you know suffered a serious injury after undergoing an atherectomy using a Medtronic HawkOne device to remove arterial plaque from your blood vessels, contact us. Our product liability attorneys have decades of experience fighting large corporations in dangerous medical device litigation and getting people compensation for their injuries. We can provide you with a free case evaluation. Contact us now.