On Jan 21, U.S. Food and Drug Administration (FDA) issued a Class I recall for a Medtronic atherectomy device after receiving reports of a potentially fatal error. Medtronic’s HawkOne Directional Atherectomy System was recalled due to the potential for arterial damage during usage.

The HawkOne Directional Atherectomy System is a medical device used in surgical procedures to clear plaque from the walls of arteries that obstruct blood flow. 

Atherectomies are performed by making a small incision in the artery and then inserting the device and scraping the arterial walls of plaque. This method is a less invasive procedure than an angioplasty, in which a balloon-like device is fed through an artery to scrub plaque.

The reason for the HawkOne Directional Atherectomy System’s recall lies in a potentially fatal design flaw. According to the FDA, there is a potential for the guidewire in the device to protrude downward out of the device shaft when force is applied. When this occurs, the device loses stability and the sharpened tip of the catheter can break off from the device and be swept along the artery. 

The FDA reports that if this occurs, serious injuries could result, including:

  • Tearing or slicing on the internal artery (arterial dissection)
  • Puncturing or rupturing the artery (arterial rupture)
  • Blockage of an artery resulting in decreased blood flow (ischemia)

In addition to injuries caused by the wandering catheter tip, there may also be additional surgeries and procedures to capture and remove the tip, which could place the patient at increased risk of common surgical complications such as infection, hemorrhage or embolism.

This class I recall will affect over 95,000 devices in use across the U.S. distributed between January 22, 2018 and October 4, 2021. The FDA reports that Medtronic sent an urgent medical device notice letter to their consumers asking them to ensure that they note the warnings and precautions contained therein. 

Patients concerned about the risk of complications with a HawkOne Directional Atherectomy System may want to discuss alternative options with their surgeon or healthcare provider.