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Table Of Contents
- HawkOne Directional Atherectomy System Lawsuit Overview
- Latest HawkOne Directional Atherectomy System Lawsuit Updates
- FDA Reports and Statistics
- HawkOne Directional Atherectomy System Injuries & Side Effects
- Do You Qualify for a HawkOne Directional Atherectomy System Lawsuit?
- HawkOne Directional Atherectomy System Recall Information
- Statute of Limitations for HawkOne Directional Atherectomy System Lawsuits
- FAQs
- 1. How can I find out if the HawkOne Directional Atherectomy System used in my procedure was part of a recall?
- 2. What compensation might be available through the HawkOne Directional Atherectomy System lawsuit?
- 3. What evidence is needed to support a claim in the HawkOne Directional Atherectomy System lawsuit?
- 4. What is the HawkOne Directional Atherectomy System used for?
- 5. How serious is an FDA Class I recall?
- 6. What should I do if I experienced complications after a procedure with this device?
- 7. Can I still file a lawsuit if my procedure was performed before the recall was announced?
- 8. How long does it typically take to resolve a medical device lawsuit?
- 9. Do I need to pay upfront fees to pursue a HawkOne lawsuit?
- 10. What makes the HawkOne device defective?
- Get a Free HawkOne Directional Atherectomy System Lawsuit Evaluation With Our Lawyers
HawkOne Directional Atherectomy System Lawsuit Overview
HawkOne Directional Atherectomy System lawsuits are emerging following a serious FDA Class I recall due to catheter tip breakage during medical procedures.
The primary allegations against Medtronic Inc. involve manufacturing defects that cause the catheter tip to break off or separate during use, leading to serious injuries including arterial dissection and rupture.
The FDA has documented at least 163 complaints, including 15 injuries, related to this defective medical device. The recall was initiated on January 21, 2022, affecting devices distributed from January 22, 2018, to October 4, 2021.
Latest HawkOne Directional Atherectomy System Lawsuit Updates
- January 21, 2022 – The FDA issued a Class I recall for the HawkOne Directional Atherectomy System due to risk of catheter tip breakage, with 163 complaints and 55 injuries reported, creating grounds for potential product liability lawsuits [1].
- December 6, 2021 – Medtronic Inc. sent an “Urgent Medical Device Notice” letter to customers warning of serious safety risks and requesting immediate implementation of safety protocols before device use [2].
- October 4, 2021 – Distribution of the recalled HawkOne Directional Atherectomy Systems ended, marking the final date of potentially defective devices entering the market [3].
FDA Reports and Statistics
The FDA Class I recall of the HawkOne Directional Atherectomy System represents the most serious type of medical device recall.
According to FDA reports, there have been at least 163 complaints related to catheter tip breakage issues, with 15 documented injuries requiring medical intervention.
The recall affects devices distributed over nearly four years, from January 22, 2018, through October 4, 2021.
This recall classification indicates that use of the device may cause serious adverse health consequences or death, making it a significant safety concern for patients who underwent procedures with this device.
HawkOne Directional Atherectomy System Injuries & Side Effects
Patients who underwent procedures with the HawkOne Directional Atherectomy System have experienced serious complications when the catheter tip breaks off or separates during use.
Serious injuries and side effects include:
- Arterial Dissection: Tears along the inside wall of arteries caused by device malfunction
- Arterial Rupture: Complete breakage or rupture of arterial walls requiring emergency intervention
- Ischemia: Decreased blood flow to body parts due to blocked arteries from device fragments
- Blood Vessel Complications: Serious vascular injuries requiring surgical repair and additional procedures
- Embolization: Migration of detached catheter tip fragments through the bloodstream
- Emergency Medical Intervention: Need for immediate surgical procedures to remove device fragments
Do You Qualify for a HawkOne Directional Atherectomy System Lawsuit?
You may qualify for a HawkOne Directional Atherectomy System lawsuit if:
- You underwent a procedure using the HawkOne Directional Atherectomy System between January 22, 2018, and October 4, 2021
- You experienced serious side effects including arterial dissection, arterial rupture, ischemia, blood vessel complications, or device fragment migration
- The injuries required emergency medical treatment, additional procedures, or hospitalization
- You can provide medical documentation linking your injuries to the HawkOne device malfunction
- You required surgical repair or additional procedures to address complications from the device
Evidence Required for a HawkOne Directional Atherectomy System Lawsuit
Strong evidence is crucial for a successful HawkOne lawsuit. Required documentation includes:
- Medical records documenting the procedure using the HawkOne Directional Atherectomy System and subsequent complications
- Hospital records showing emergency medical intervention or additional procedures
- Expert testimony linking the device malfunction to your specific injuries
- Communication with healthcare providers regarding device complications
- Documentation of the specific device model and serial number used in your procedure
- Records of any surgical repairs required due to device-related complications
Damages You Can Recover
Compensation through HawkOne Directional Atherectomy System lawsuits may include:
- Medical expenses: Reimbursement for emergency treatment, additional procedures, and ongoing medical care
- Lost wages: Compensation for time away from work due to complications and recovery
- Pain and suffering: Damages for physical pain and emotional distress caused by device malfunction
- Punitive damages: Additional compensation if manufacturer negligence in addressing device defects is proven
HawkOne Directional Atherectomy System Recall Information
Recall Details:
- Recall Date: January 21, 2022
- Recall Classification: FDA Class I (most serious type)
- Distribution Period: January 22, 2018, to October 4, 2021
- Manufacturer: Medtronic Inc.
- Reason: Risk of catheter tip breakage or separation during use
- Reported Issues: 163 complaints, including 15 injuries
“Medtronic Inc. is recalling this product due to the risk of the guidewire within the catheter moving downward or prolapsing when force is applied during use. If this happens, the catheter tip may break off or separate and this could lead to serious adverse events including a tear along the inside wall of an artery (arterial dissection), a rupture or breakage of an artery (arterial rupture), decrease in blood flow to a part of the body because of a blocked artery (ischemia), and/or blood vessel complications that could require surgical repair and additional procedures to capture and remove the detached and/or migrated (embolized) tip.”- FDA.
Statute of Limitations for HawkOne Directional Atherectomy System Lawsuits
Time limits for filing HawkOne Directional Atherectomy System lawsuits vary by state, typically ranging from 1-3 years from the date of injury discovery.
Given that the recall was announced in January 2022, it’s crucial to act quickly as statute of limitations deadlines may be approaching for patients who experienced complications.
Consulting with an experienced medical device attorney immediately is essential to preserve your legal rights and ensure your case is filed within the required timeframe.
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FAQs
1. How can I find out if the HawkOne Directional Atherectomy System used in my procedure was part of a recall?
To check if the HawkOne Directional Atherectomy System used in your procedure was recalled, contact the hospital or healthcare provider who performed the procedure. Recall information is available on the FDA website or through the manufacturer.
2. What compensation might be available through the HawkOne Directional Atherectomy System lawsuit?
Compensation in the HawkOne lawsuit could include reimbursement for medical expenses, lost wages, pain and suffering, and possibly punitive damages if it is proven the manufacturer was negligent in addressing the device’s defects.
3. What evidence is needed to support a claim in the HawkOne Directional Atherectomy System lawsuit?
To support a claim, you’ll need medical records documenting your procedure and complications, expert testimony linking the device to your injuries, and any communication from healthcare providers about using the device.
4. What is the HawkOne Directional Atherectomy System used for?
The HawkOne Directional Atherectomy System is used to remove blockages from peripheral arteries and improve blood flow. It has been recalled due to risks of catheter tip breakage during use.
5. How serious is an FDA Class I recall?
An FDA Class I recall is the most serious type, indicating that the device could cause severe health consequences or even death. This shows the significant safety risks associated with the HawkOne device.
6. What should I do if I experienced complications after a procedure with this device?
If you experienced complications from the HawkOne Directional Atherectomy System, get immediate medical help if needed, and consult a medical device attorney to discuss your legal options. Be aware that time limits for filing lawsuits may apply.
7. Can I still file a lawsuit if my procedure was performed before the recall was announced?
Yes, you can file a lawsuit if your procedure using the HawkOne device was between January 22, 2018, and October 4, 2021, and you experienced complications. The recall date doesn’t affect your eligibility to seek legal action for injuries that occurred earlier.
8. How long does it typically take to resolve a medical device lawsuit?
The duration can vary widely, from several months to years, depending on case complexity, evidence availability, and whether the case settles or goes to trial. Your attorney can give you a more accurate timeline based on your case.
9. Do I need to pay upfront fees to pursue a HawkOne lawsuit?
Most medical device attorneys operate on a contingency fee basis, meaning you pay nothing upfront. You’ll only pay attorney fees if they successfully secure compensation for your case. Initial consultations are usually free.
10. What makes the HawkOne device defective?
The HawkOne device is defective because the guidewire within the catheter can prolapse or move when force is applied, causing the catheter tip to break off. This design flaw poses serious safety risks for patients.
See all related medical device torts we’ve taken on.
Get a Free HawkOne Directional Atherectomy System Lawsuit Evaluation With Our Lawyers
Time is limited to pursue legal action for HawkOne Directional Atherectomy System complications. Statute of limitations deadlines vary by state but typically range from 1-3 years from injury discovery.
With the recall announced in January 2022, patients who experienced earlier complications may face approaching deadlines.
Our legal team at Schmidt & Clark, LLP offers:
- Free, confidential consultations to evaluate your HawkOne case
- No upfront costs or fees – we only get paid if we win your case
- Experienced representation in medical device litigation nationwide
- Comprehensive case evaluation and evidence gathering
- Dedicated support throughout the legal process
If you or a loved one was injured, you should contact our law firm immediately. Consumers may be entitled to a settlement by filing a lawsuit, and our lawyers can help you receive fair compensation.
References
- https://www.tctmd.com/news/hawkone-directional-atherectomy-system-recalled-due-risk-tip-breakage
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=190894
- https://evtoday.com/news/medtronics-hawkone-directional-atherectomy-system-recalled