Medtronic TurboHawk

2022: Withdrawal of defective devices

On February 7, 2022 Medtronic announced a voluntary response of a system of the directed aterektomiya of TurboHawk 6 French (6Fr) Plus. It is used to eliminate blockage of peripheral arteries and improve blood flow. Recall of the system is associated with the risk of damage to the tip as a result of falling out of the guide wire.

Medtronic indicated that the recall affects about 800 TurboHawk Plus devices. Recall was initiated due to the risk of conductor displacement inside the catheter down or falling out when force was applied during use. If this happens, the tip of the catheter may break or detach, resulting in serious injury to the patient. However, by February 2022, there were no reports of tip damage and injuries or fatalities related to the TurboHawk 6 French (6Fr) Plus device. The company conducted a review based on the similarity of design between the TurboHawk Plus and HawkOne systems. Consequently, the same warnings and precautions apply.

Medtronic recalls defective devices for removing plaques from vessels. They seriously worsen health

At the end of January 2022, Medtronic announced the recall of defective medical devices for removing plaques from arterial vessels. HawkOne The company took this step after receiving many reports of injuries received when using the system to clear blocked arteries. According to a recall notice from the U.S. Food and Drug Administration, the agency received 163 complaints about the device related to 55 injuries and zero deaths.

Medtronic does not require the extraction or disposal of its products, nor does it require any action for patients treated with TurboHawk Plus 6Fr. Other devices from the company for directed atherectomy from Medtronic are valid and do not fall under the general review of TurboHawk 6 French (6Fr) Plus and HawkOne.^[1]

Notes