The U.S. FDA announces that Medtronic is recalling a directional atherectomy system, which is used during procedures intended to remove blockage from peripheral arteries and improve blood flow.
Medtronic has recalled the TurboHawk Plus directional atherectomy system, used in the peripheral arteries, due to the risk of catheter-tip damage during use, the US Food and Drug Administration announced Wednesday. The agency deemed the action a Class I recall, the most serious type.
No injuries related to use of TurboHawk Plus have been reported as of February 7, 2022. The recall was spurred by the system’s design, which is similar to that of the HawkOne directional atherectomy system (also Medtronic) that was recently recalled following reports of 55 injuries—but no deaths—related to its use.
The issue stems from the guidewire prolapsing when force is applied, which can lead to the tip of the catheter breaking off or separating. That, in turn, can cause arterial dissection or rupture, ischemia, or vessel complications requiring surgical repair or additional procedures.
According to the FDA, on Feb. 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.
- Prior to use, review the Instructions For Use (IFU) included with your product, noting the warnings and precautions listed in this letter.
The FDA also said Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX
Read the full article at TCTMD.
