Medtronic HawkOne Directional Atherectomy System Recall Issued Over Broken Tip Risks

Officials have announced a Class I recall of Medtronic catheter guidance systems that could break during use.

Federal safety officials have announced a recall of Medtronic HawkOne Directional Atherectomy Systems, which are used to clear out clogged arteries, indicating that dozens of injuries have resulted from catheter tips breaking during use, which may cause life-threatening injuries for patients.

The Medtronic HawkOne Directional Atherectomy Systems recall was announced by the FDA on January 21, indicating that patients may require emergency medical intervention if the system’s catheter tip breaks off or separates during use. As a result of the serious risks associated with the Medtronic HawkOne, the agency designated the action as a Class I recall.

The devices consist of a catheter and cutter driver that are used for procedures intended to remove blockages from peripheral arteries and improve patient blood flow. According to the recall, when downward force is applied to the guidewire within the catheter, it may suddenly cause the tip of the catheter to break off or separate, which may lead to a series of potential adverse health consequences for patients.

Specifically, the FDA is warning that in the event of a catheter tip breaking off, the patient could suffer from arterial dissection or arterial rupture, which is when a tear occurs along the side wall of an artery, or when an artery ruptures or breaks. In both scenarios, patients may be at risk of serious and potentially fatal internal bleeding events.

The recall warns a broken catheter event may also cause an artery to become blocked or cause blood vessel complications which could significantly reduce a patient’s blood flow, requiring surgical intervention and repair to remove and retrieve the broken catheter tip.

To date, Medtronic has become aware of 163 complaints regarding the recalled HawkOne systems, which have resulted in 55 patient injuries. While no deaths have been reported to date, the FDA has categorized this recall as a Class I recall, indicating it is the most serious of its kind, and the use of the product causes an increased risk of injury or death to patients.

The recall includes approximately 95,110 Medtronic HawkOne Directional Atherectomy System distributed from January 22, 2018 through October 4, 2021 to various healthcare facilities and hospitals across the U.S.

Medtronic Inc. released an Urgent Medical Device Notice letter on December 6, 2021, instructing organizations to review the updated “Instructions For Use’ highlighting the warnings and precautions to prevent catheter tip separations and breaks.

Customers with questions or concerns regarding the catheter system recall are being encouraged to contact Medtronic Customer Service at 800-854-3570 and to report any adverse reactions or quality problems with the HawkOne systems to the FDA Safety Information and Adverse Event Reporting Program.

Catheter Recall Injuries

Over the last several years, the FDA has become aware of a rising number of catheter injuries and deaths linked to Medtronic, Penumbra and other catheter designs offered by medical device manufacturers. Many have resulted in Class I recalls over catheter tips breaking and becoming lodged in blood vessels, among other serious and sometimes fatal injuries.

In November 2020, a Medtronic catheter recall was issued for Rashkind Balloon Septostomy Catheters used to enlarge an existing atrial septal defect as a treatment options for patients diagnosed with congenital heart defects, such as low blood oxygen levels.

The recall was categorized as a Class I recall by the FDA following reports of several catheter injuries and one death, which warned patients the catheters may break or separate during use which could increase the risk of serious and permanent blood vessel injuries.

In February 2021, a Penumbra Jet 7 Reperfusion Catheters recall impacting nearly 31,000 units was announced by the FDA following 20 medical device reports describing at least 14 unique patient deaths.

According to the recall, patients suffered from vessel damage, hemorrhage, and cerebral infarction believed to be caused by the Penumbra catheters. Penumbra now faces a catheter class action lawsuit that was filed in January 2021 seeking to represent investors who lost money when the company’s stock value plummeted due to the recall.