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02/25/22   |   By

Medtronic HawkOne System Recalled After Increased Risk of Injury, Death

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Medtronic HawkOne Directional Atherectomy System Recalled After Increased Risk of Injury, Death

The Food and Drug Administration (FDA) has issued a Class I recall for the Medtronic Inc. HawkOne Directional Atherectomy System after serious injury was reported after its use to remove blockages from peripheral arteries. A Class I recall is the more serious recall by the FDA as the use of these devices can result in serious injury or death.

If you are a patient who experienced serious injury or have lost a loved one after a procedure using the HawkOne device, Regan Zambri Long can help.

What is the HawkOne Directional Atherectomy System?

According to Medtronic, The HawkOne device is used to, “restore blood flow by removing plaque in patients with peripheral arterial disease (PAD). The HawkOne device treats all plaque morphologies, including severe calcium.”

The device includes a catheter with a cutter driver, torquer knob, and a distal flush tool.

What Caused the Medtronic Recall?

Medtronic Inc. has moved forward with the recall due to a heightened risk of the guidewire within the catheter prolapsing or moving downward when force is applied during a procedure.

Should the catheter prolapse, patients are at increased risk of tearing along the inside wall of an artery (arterial dissection), a rupture or breakage of an artery (arterial rupture), decreased blood flow (ischemia), or other blood vessel complications resulting in additional surgical procedures.

The FDA has been made aware of 163 complaints about the device and reports 55 injuries following its use. At this time, no deaths have been reported following the use of the defective device.

How Many HawkOne Devices Have Been Recalled as a Result?

Medtronic Inc. began distributing the HawkOne Directional Atherectomy System from January 22, 2018, till October 4, 2021. The recall was issued on December 6, 2021, with Medtronic sending consumers an “Urgent Medical Device Notice” which requested:

  • The recall will be shared within the impacted organizations where the device may have been utilized.
  • That medical providers review the “Instructions For Use” included with the product, including the warnings and precautions listed in the “Urgent Medical Device Notice”.
  • That consumers complete a customer confirmation form enclosed in the letter and email correspondence.

In the United States, 95,110 devices were recalled as a result.

Who Is at Risk After Use of the HawkOne Device?

The FDA has listed affected individuals in the recall as those health care providers using the HawkOne Directional Atherectomy System and patients who received treatment with the HawkOne Directional Atherectomy System.

My Doctor Used the HawkOne Directional Atherectomy System During a Procedure and I Was Hurt. What Can I Do?

If you or a loved one were seriously injured following the use of the HawkOne Directional Atherectomy System, you may be able to file a product liability lawsuit for a defective medical device.

In addition, other parties may also share in the liability for your injuries including the:

Who can be found liable for your injuries ultimately comes down to the facts of your unique case.

For example, the product manufacturer may be at fault if it was known that there were defects with the device, or that the company relied on deceptive marketing techniques.

Further, the hospital or doctor who used the device during your procedure could also be held liable if it was known that there were risks associated with the medical device’s use, and they failed to warn you of those risks.

Hurt After Use of a Defective Medical, Surgical Device? Call Regan Zambri Long.

Best Lawyers 2022If you or a loved one suffered injury or death following medical therapy or surgery with the Medtronic Inc. HawkOne Directional Atherectomy System, or another defective device, you may be entitled to a defective medical device claim.

The unsafe medical device lawyers of Regan Zambri Long can help you secure the compensation you deserve for your losses.

With more than 100 years of combined experience, our lawyers know that when medical devices intended to help patients cause more harm, justice must be served. Our team works alongside industry experts to understand the full scope of your medical needs, helping secure your compensation.

For a no-obligation, free consultation, contact the defective medical device lawyers at Regan Zambri Long at (202) 960-4596 or contact us online.

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