Medtronic Recalls TurboHawk Plus Atherectomy System
The system has a design similar to another that has been associated with injuries related to catheter-tip damage.
Medtronic has recalled the TurboHawk Plus directional atherectomy system, used in the peripheral arteries, due to the risk of catheter-tip damage during use, the US Food and Drug Administration announced Wednesday. The agency deemed the action a Class I recall, the most serious type.
No injuries related to use of TurboHawk Plus have been reported as of February 7, 2022. The recall was spurred by the system’s design, which is similar to that of the HawkOne directional atherectomy system (also Medtronic) that was recently recalled following reports of 55 injuries—but no deaths—related to its use.
The issue stems from the guidewire prolapsing when force is applied, which can lead to the tip of the catheter breaking off or separating. That, in turn, can cause arterial dissection or rupture, ischemia, or vessel complications requiring surgical repair or additional procedures.
The TurboHawk Plus recall—initiated February 4, 2022—affects 686 devices in the United States manufactured between July 21, 2021, and January 25, 2022.
In an Urgent Medical Device Notice, Medtronic informed its customers that it is not requesting product retrievals or disposals. “Prior to use, review the Instructions For Use (IFU) included with your product, noting the warnings and precautions listed in this letter,” the company said.