Medtronic recalled 95,110 HawkOne Directional Atherectomy Systems after 55 people were injured during procedures to remove blockages in their blood vessels.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Medtronic HawkOne System induced injury cases in all 50 states. If you or somebody you know has been injured, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Medtronic Recalls HawkOne Directional Atherectomy System
In January 2022, Medtronic and the FDA announced a Class 1 recall for about 95,110 HawkOne Directional Atherectomy Systems due to a risk of severe, life-threatening injuries or deaths.
What is the HawkOne System?
The HawkOne System is a medical device that is designed with a catheter and a cutter driver. It is used to remove blockages from peripheral arteries and improve blood flow.
What is the Problem?
Medtronic recalled the HawkOne System because the guidewire inside the catheter can moving downward or prolapse when force is applied during use.
What is the Risk?
If the guidewire moves downward or prolapses, the catheter tip may break off or separate and cause the following serious injuries:
- Tear along the inside wall of an artery (arterial dissection)
- Rupture or breakage of an artery (arterial rupture)
- Decrease in blood flow to a part of the body because of a blocked artery (ischemia)
- Blood vessel complications that require surgical repair
- Additional procedures to capture and remove the detached and/or migrated (embolized) tip
How Many People Were Injured?
Medtronic issued the recall after 163 complaints and 55 reports of injuries related to the HawkOne System’s guidewire moving downward or prolapsing. No deaths were reported.
Do I have a Medtronic HawkOne System Lawsuit?
The Schmidt Firm, PLLC is currently accepting Medtronic HawkOne System induced injury cases in all 50 states. If you or somebody you know has been injured, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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