WASHINGTON, D.C. – The U.S. Food and Drug Administration has announced a Class I recall of 95,000 Hawkone Directional Atherectomy Systems due to potential injury or death. The FDA’s announcement states that the manufacturer has received 55 injury complaints concerning the medical device. Fortunately, no fatalities have been documented at this time. The recalled Hawkone Directional Atherectomy devices were sold from January 2018 until October 2021.
The key distinction between this recall and others is that Medtronic will not recover the recalled devices. Medtronic stated that the potential of prolapse is explicitly emphasized in the medical device’s warning information. However, Medtronic did not want to administer a device recall to accentuate the seriousness of the problem. A statement from Medtronic reads, “The purpose of this recall is to reiterate existing warnings and precautions in the HawkOne Instructions for Use related to the risk associated with tip damage caused by guidewire prolapse.”
Medtronic also highlighted that customers are not required to take any actions concerning the recall. For additional information and contact information for Medtronic click here.
If you or a loved one have been harmed by a Hawkone Directional Atherectomy Systems or any other product, you may be qualified to file a claim against the manufacturer and other responsible parties. Do not miss the time limitations and contact Parker Waichman LLP today for your free consultation.
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