The FDA has announced a Class 1 recall for about 95,110 HawkOne Directional Atherectomy Systems manufactured by Medtronic.
The devices are used during to restore blood-flow by removing blockages in peripheral arteries. They are designed with a catheter and a cutter driver.
The problem is that a guidewire inside the catheter can prolapse or move downward when pressure is applied. If this happens during a procedure, the patient can suffer life-threatening injuries or death.
If the device malfunctions, the greatest risk is that it will damage an artery and cause massive internal bleeding that requires emergency surgery. The tip of the device can also break off in a patient’s body.
The recall was announced after at least 55 patients were injured. There were also 163 complaints about the guidewire moving downward or prolapsing out of the device, or the tip breaking off.
Some of the most serious injuries include an arterial dissection (tear along the inside wall of the artery), arterial rupture, decrease in blood-flow to part of the body due to a blocked artery, blood vessel complications that require emergency surgery, or the need for additional procedures to remove the broken tip of the catheter.
For more information, customers with questions about this recall can contact their Medtronic Field Representative or call Medtronic Customer Service at (800) 854-3570.