FDA MedWatch - TurboHawk Plus Directional Atherectomy System by Medtronic
U.S. Food and Drug Administration sent this bulletin at 03/09/2022 12:20 PM EST
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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
TOPIC: TurboHawk Plus 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 (correcting) this product due to design similarities shared with another device that was recently recalled for correction. There is a 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.
As of February 7, 2022, there have been no reported injuries or deaths associated with this problem.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The TurboHawk Plus Directional Atherectomy System consists of a catheter and a cutter driver. This device is used during procedures intended to remove blockage from peripheral arteries and improve blood flow.
RECOMMENDATIONS: On February 4, 2022, Medtronic sent all affected customers an Urgent Medical Device Notice requesting they take the following actions:
Be aware, there are no product retrievals or disposals requested by Medtronic.
Share Notice with all those who need to be aware within your organization or to any organization where the products have been transferred.
Customers who have questions about this recall should contact the company.
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:
