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Why was the Medtronic HawkOne Directional Atherectomy System Recalled?
This FDA Class I Recall [1] began on January 21, 2022, and was initiated because patients may require emergency medical intervention if the system’s catheter tip breaks off or separates during use.
"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," FDA said. "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."
To date, there have been at least 163 complaints, including 15 injuries, related to this issue, FDA said.
The recalled HawkOne Directional Atherectomy Systems were distributed from January 22, 2018 to October 4, 2021.
What is the HawkOne Directional Atherectomy System?
The HawkOne Directional Atherectomy System consists of a catheter and a cutter driver. This device is used during procedures intended to remove blockage from peripheral arteries and improve blood flow.
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FDA Recommendation
On December 6, 2021, Medtronic Inc. sent an “Urgent Medical Device Notice" letter to customers requesting they:
- Share with all those who need to be aware within the organization or to any organization where the products have been transferred.
- Before using the HawkOne Directional Atherectomy System, review the “Instructions For Use” included with the product, noting the warnings and precautions listed in the “Urgent Medical Device Notice” letter.
- Complete the Customer Confirmation Form enclosed in the “Urgent Medical Device Notice" letter
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The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in HawkOne Directional Atherectomy System Lawsuits. We are handling individual litigation nationwide and currently accepting lawsuits in all 50 states.
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.
