Medtronic recalls Directional Atherectomy System due to risk of tip damage during use

January 21, 2022

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Medtronic is recalling its HawkOne Directional Atherectomy System due to the risk of catheter tip damage during use, which may include rupture or separation of the catheter tip, according to a press release from the company. FDA.

The FDA has identified this as a Class I recall, the most serious type of recall, meaning that use of these devices could result in serious injury or death. There have been 163 complaints about this device issue, 55 injuries and no fatalities reported, according to the statement.

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The HawkOne Directional Atherectomy System consists of a catheter and a screwdriver. According to the FDA, Medtronic is recalling this product due to the risk of the guidewire inside the catheter moving downward or prolapse when force is applied during use. The release noted that tip damage to the Directional Atherectomy System could result in serious adverse events such as arterial dissection, arterial rupture, ischemia, and/or blood vessel complications that may require surgical repair and additional procedures to capture and remove the detached and/or migrated. point.

This device is used during procedures to eliminate obstruction of peripheral arteries and improve blood circulation. The recalled devices were distributed between January 22, 2018 and October 4, 2021.

On December 6, 2021, Medtronic sent an “Urgent Medical Device Notice” letter to customers asking them to share with anyone who needs to know where the products have been transferred; review the operating instructions before using the system, noting the warnings and precautions listed in the letter; and complete an attached Customer Confirmation Form.

The statement says customers with questions about this recall should contact their Medtronic field representative or call Medtronic Customer Service at 800-854-3570.

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