The FDA has issued a Class 1 recall, which is the most serious kind of recall, for HawkOne Directional Atherectomy Systems. When a Class 1 recall is issued, it is because using the recalled device may cause death or severe injuries. If you were injured or a loved one was killed because of the HawkOne Directional Atherectomy System, you may have grounds to sue and should contact the experienced Chicago-based product liability lawyers of Moll Law Group about whether you have a viable claim. Billions have been recovered in cases with which we’ve been involved.
Give Moll Law Group a Call About HawkOne Directional Atherectomy Systems Injuries
The HawkOne Directional Atherectomy System is used by surgeons to improve blood flow during procedures. Made up of a catheter and cutter driver, it is used to take out blockages that occur in peripheral arteries. Unfortunately, when it is used forcefully, there is a risk of the guidewire inside the catheter shifting down or prolapsing, which can result in the tip of the catheter breaking away or separating. This can then result in significant adverse events such as an arterial dissection in which the inside wall of the artery is torn. The tip breaking off can also decrease blood flow resulting in arterial rupture or ischemia. When there are blood vessel complications, further procedures may need to be conducted to catch and take out the tip that has detached. Sometimes the tip migrates, creating further complications.
Medtronic sent an Urgent Medical Device Notice letter to consumers on December 6, 2021, because it has already received 163 complaints about the device. While no deaths have been reported, there have been 55 injuries so far. Prior to the recall, consumers and health care providers were asked to share the information with anyone at the practice or organization who needs to be aware of this problem, or to any other organization where the product has been sent. Health care providers were asked to review instructions. Even so, injuries and deaths may have occurred as a result of the defective device.
Product Liability Lawsuit
When a medical device is defective in terms of its marketing, manufacturing or design, and this defect results in injuries, it may be appropriate to pursue damages in a product liability lawsuit. In the case of the HawkOne Directional Atherectomy, there may be design failures since multiple tips have already broken off and caused trouble. However, prior to the recall, there may have been marketing defects, which often consist of failures to adequately warn of risks.
In some states, a rule that’s called the learned intermediary doctrine may apply. It states that when a doctor is adequately informed and prescribes drugs or medical devices to patients, the chain of liability is broken. When this applies, you may have a claim against the doctor rather than the manufacturer. The doctrine only applies, however, if the doctor has been appropriately warned of the risks of the device. So, this doctrine could apply to cases arising after Medtronic sent its December letter.
Call Our Law Firm About Your Product Liability Lawsuit
If you were injured or a loved one was killed due to a problem with the HawkOne Directional Atherectomy, you should consult the seasoned Chicago product liability lawyers of Moll Law Group about whether you have a viable claim against its manufacturers. We represent plaintiffs across the country. Please complete our online form or give us a call at 312.462.1700.