Medtronic, Inc. has recalled its HawkOne Directional Atherectomy System due to the risk of catheter tip separation or breakage. The Class I recall affects more than 95,000 devices in the United States, which were distributed between January 22, 2018 and October 4, 2021.
The atherectomy system is used to remove blockage from peripheral arteries and improve blood flow. However, the guidewire within the catheter could move down or prolapse when force is applied, which could cause the catheter tip to either break off or separate. Resulting serious adverse events include an arterial dissection or rupture, ischemia, and blood vessel complications that could lead to additional surgical procedures.
Thus far, 163 complaints have been made about the device, with 55 injuries. No deaths linked to this device issue have been reported.
Medtronic sent customers an Urgent Medical Device Notice on December 6, 2021. It also provided the following statement:
“In accordance with our commitment to patient safety, Medtronic recently initiated a voluntary recall to customers related to the risk associated with tip damage caused by guidewire prolapse in its 6 French (6Fr) HawkOne™ directional atherectomy system. This recall has been classified by the FDA as a Class I recall.
In our letter to customers, Medtronic noted that a small number of customer reports of tip damage (at a rate of 0.168% when compared to quantity of devices distributed) during the use of the 6FR HawkOne devices. While most of these instances were resolved without patient issue, a small number required endovascular retrieval (0.033%) or open surgical retrieval (0.028%). No patient deaths have been reported related to this issue.
There are no product retrievals or disposals requested associated with this recall. The purpose of this recall is to reiterate existing warnings and precautions in the HawkOne Instructions for Use (IFU) related to the risk associated with tip damage caused by guidewire prolapse. Additionally, there are no actions required for patients treated with the HawkOne 6Fr or any Medtronic directional atherectomy devices. Physicians should continue to monitor patients in accordance with their medical facility’s standard care protocols.” – Medtronic