The US Food and Drug Administration (FDA) has sent out a class one recall, the most serious level of recall, for Styrker’s Trevo XP ProVue retriever. This device is intended for the removal of blood clots during acute ischaemic stroke.
The Trevo XP ProVue Retriver has been recalled due to a risk that the core wire in the device may break or become separated during use. If this occurs during an operation, it may result in the device being left inside a patient’s blood vessel or tissue.
The device being left inside a patient may result in adverse problems such as bleeding, additional blockage, disability, and death. There have been 11 reports of injury or illness, and one death.
So far 1,258 devices have been recalled in the USA. The devices were manufactured between July of 2019 and September of 2019, and distributed from September of 2019 to July of 2020. Stryker themselves issued a recall for this product in September of 2020.