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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
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TOPIC: HawkOne Directional Atherectomy System by Medtronic: Class I Recall - Due to Risk of Tip Damage During Use
AUDIENCE: Patient, Health Professional, Risk Manager, Cardiology
ISSUE: Medtronic is recalling this product due to the risk of the guidewire within the catheter moving downward or prolapsing when force is applied during use. If this happens, 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.
There have been 163 complaints about this device issue. There have been 55 injuries and no deaths reported about this device issue.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The HawkOne Directional Atherectomy System is used during procedures intended to remove blockage from peripheral arteries and improve blood flow.
RECOMMENDATIONS: On December 6, 2021, Medtronic sent an “Urgent Medical Device Notice" letter to customers requesting they:
- Share with all those who need to be aware within the organization or to any organization where the products have been transferred.
- Before using the HawkOne Directional Atherectomy System, review the “Instructions For Use” included with the product, noting the warnings and precautions listed in the “Urgent Medical Device Notice” letter.
- Complete the Customer Confirmation Form enclosed in the “Urgent Medical Device Notice" letter and email to the company.
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Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
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Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
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