Medtronic recalls directional atherectomy system due to risk for tip damage during use
Medtronic is recalling its HawkOne Directional Atherectomy System due to risk for the tip of the catheter becoming damaged during use, which may include the catheter tip breaking off or separating, according to an FDA press release.
The FDA has identified this as a class I recall, the most serious type of recall, meaning use of these devices may cause serious injuries or death. There have been 163 complaints about this device issue, 55 injuries and no deaths reported, according to the release.
The HawkOne Directional Atherectomy System consists of a catheter and a cutter driver. According to the FDA, 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. The release noted the tip damage to the directional atherectomy system could lead to serious adverse events such as arterial dissection, arterial rupture, ischemia and/or blood vessel complications that could require surgical repair and additional procedures to capture and remove the detached and/or migrated tip.
This device is used during procedures intended to remove blockage from peripheral arteries and improve blood flow. Recalled devices were distributed between Jan. 22, 2018, and Oct. 4, 2021.
On Dec. 6, 2021, Medtronic sent an “urgent medical device notice" letter to customers requesting they share with all those who need to be aware where the products have been transferred; review the instructions for use before using the system, noting the warnings and precautions listed in the letter; and complete an enclosed customer confirmation form.
The release noted that customers who have questions about this recall should contact their Medtronic field representative or call Medtronic customer service at 800-854-3570.
On February 7, Medtronic announced it issued a voluntary recall of approximately 800 units of its TurboHawk Plus Directional Atherectomy System because it has a similar design to the HawkOne system. There have been no reports of tip damage, injury or death associated with the TurboHawk Plus system, and there are no requests for retrieval or disposal of the devices, according to the company.
Editor’s Note: This article was updated on Feb. 7, 2022 with the new information about TurboHawk Plus.