Medtronic HawkOne

2022: Recall defective systems for removing plaques from arterial vessels

At the end of January 2022, Medtronic announced the recall of defective medical devices for removing plaques from arterial vessels. HawkOne The company took this step after receiving many reports of injuries received when using the system to clear blocked arteries.

The recall covers more than 95 thousand devices sold in the United States since 2018. HawkOne the last device to be labeled Class I, the most critical type, by the Food and Drug Administration (FDA). The system includes a catheter and a drive cutter designed to remove plaques inside peripheral arteries by rotating at a speed of up to 12 thousand revolutions per minute. The problem is related to the guide wire of the device, which can bend and protrude outside during use in a medical operation.

Medtronic recalls defective HawkOne systems to remove plaques from arterial vessels

This problem can cause the catheter tip to detach or break off, potentially leading to serious complications, including rupture or blockage of the blood vessel, requiring surgery to repair the artery and remove the device. According to the FDA recall notice, the agency received 163 complaints about the device related to 55 injuries and zero deaths.

In a letter dated December 2021, Medtronic notified suppliers in its FDA recall notice, the company did not require the device to be returned to the manufacturer. The letter also repeats existing warnings and precautions in the guide wire risk HawkOne instruction. No action is required for patients who have undergone the procedure without incident, and current patients must be monitored according to routine follow-up procedures, Medtronic reported.^[1]

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