Medtronic has recalled 95,110 HawkOne Directional Atherectomy Systems because of the risk of the guidewire within the catheter moving downward or prolapsing during use, which may damage the tip of the catheter.
The US Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type, because of the potential for serious injury or death.
The HawkOne Directional Atherectomy system is used during procedures intended to remove blockage from peripheral arteries and improve blood flow.
If the guideline moves downward or prolapses during use, 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 (ischemia), and/or blood vessel complications that could require surgical repair and additional procedures to capture and remove the detached and/or migrated (embolized) tip,” the FDA says in a recall notice posted today on its website.
To date, there have been 55 injuries, no deaths, and 163 complaints reported for this device.
The recalled devices were distributed in the United States between January 22, 2018 and October 4, 2021. Product codes and lot numbers pertaining to the devices are listed on the FDA website.
Medtronic sent an urgent field safety notice to customers December 6, 2021, requesting that they alert parties of the defect and review the instructions for use before using the device and note the warnings and precautions listed in the letter.
Customers were also asked to complete the enclosed confirmation form and email to [email protected]
Healthcare providers can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.
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