Medtronic recalled 95,110 HawkOne Directional Atherectomy Systems after at least 55 patients were injured when the device malfunctioned.
Need a Texas Medtronic HawkOne System Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with a severe side effect of a HawkOne Directional Atherectomy System, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
Medtronic Issues Class 1 Recall for HawkOne Directional Atherectomy System
In January 2022, the FDA announced a Class 1 recall for the Medtronic HawkOne Directional Atherectomy System due to a risk of severe injury or death.
The HawkOne Directional Atherectomy System is a medical device that is used during procedures to remove blockages in peripheral arteries and restore blood-flow.
What is the Problem?
The system is designed with a catheter and a cutter driver. Inside the catheter is a guidewide. The problem is that the guidewire can move downward or prolapse out of the device when force is applied.
If this happens when the device is inside a patient’s body, the tip may separate, or cause severe, life-threatening injuries or patient death.
Risks of Using a Recalled HawkOne System
- Severe internal bleeding
- Need for emergency open surgery
- Arterial dissection (tear along the inside wall of an artery)
- Decrease in blood-flow to part of the body due to a blocked artery
- Blood vessel complications that require surgery
- Patient may need more procedures to remove the broken tip of the catheter
How Many Injuries Were Reported?
The HawkOne System was recalled after Medtronic received 163 complaints and 55 injury reports related to the guidewire moving downward or prolapsing out of the catheter. No deaths were reported.
Need a Medtronic HawkOne System Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our law firm for a free case review.