The FDA has identified the recall as a Class I—the most serious type in that “use of these devices may cause serious injuries or death.” So far, there have been 163 complaints, 55 injuries and no deaths reported in relation to the device issue, the FDA reported.
HawkOne consists of a catheter and cutter driver, and is used during procedures intended to remove blockage from peripheral arteries. The recall was made “due to the risk of the guidewire within the [system’s] catheter moving downward or prolapsing when force is applied during use,” according to the FDA.
The company distributed an urgent medical device notice to customers on 6 December 2021, requesting they share reports of the defect with all relevant parties, and review both HawkOne’s instructions for use (IFU), and the warnings and precautions listed in the urgent notice letter, before using the product.
“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,” Medtronic said in a statement. “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%).”
The statement added that there are no product retrievals or disposals requested associated with the recall and no actions required for patients treated with HawkOne.
Should the catheter function as outlined, the FDA reported in a medical device recall advisory, “the catheter tip may break off or separate and this could lead to serious adverse events, including a tear along the inside wall of an artery (arterial dissection), a rupture or breakage of an artery (arterial rupture), decrease in blood flow to a part of the body because of a blocked artery (ischaemia), and/or blood vessel complications that could require surgical repair and additional procedures to capture and remove the detached and/or migrated (embolised) tip.”
Medtronic asked customers to complete a confirmation form enclosed in the urgent notice letter and email them to [email protected].