Medtronic’s HawkOne Directional Atherectomy System Recalled

January 21, 2022—The FDA issued an advisory that Medtronic conducted a recall of its HawkOne directional atherectomy system due to the risk of tip damage during use.

Medtronic initiated the recall on December 6, 2021, sending an “Urgent Medical Device Notice” letter to customers. The recall involves 95,110 devices distributed from January 22, 2018, to October 4, 2021. Product codes and lot numbers are available online in the FDA Recall database.

Medtronic’s letter requested customers to:

• 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 and email to rs.cfqfca@medtronic.com.

In a statement provided to Endovascular Today by Medtronic, the company advised that there are no product retrievals associated with this recall and that the purpose of the recall is to reiterate existing warnings and precautions in the HawkOne Instructions for Use. The company’s complete statement is included below.

The FDA has identified this as a Class I recall, the most serious type of recall, indicating that use of the device may cause serious injuries or death. There have been 163 complaints about this device issue, and there have been 55 injuries and no deaths reported, confirmed the FDA.

The HawkOne system is composed of a catheter and a cutter driver. The device is used during procedures intended to remove blockage from peripheral arteries and improve blood flow.

According to the FDA notice, Medtronic recalled the HawkOne due to risk of the guidewire within the catheter moving downward or prolapsing when force is applied during use. If this happens, the catheter tip may break off or separate, and this could lead to serious adverse events, including arterial dissection, arterial rupture, ischemia, and/or blood vessel complications that could require surgical repair and additional procedures to capture and remove the detached and/or embolized tip.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch via the FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or fax. More information is available in the recall advisory on the FDA website.

Medtronic issued the following statement: