The Food and Drug Administration (FDA) has announced a recall of the Trevo XP ProVue Retriever (Stryker Neurovascular) due to a safety risk.
The Trevo XP ProVue Retriever is intended to restore blood flow or remove blood clots within a blood vessel in the brain during an acute ischemic stroke. Stryker Neurovascular is recalling the Trevo XP ProVue Retriever device because there is a risk that the core wire may break or separate when the core wire is retracted during use. If this occurs, the device could be left inside the patient’s blood vessel or tissue. The use of affected devices may cause serious adverse health consequences, including bleeding, additional blockage of blood vessels, disability, and death.
There have been 11 reports of injury or illness and one death related to this device issue. The FDA has identified this as a Class I recall, the most serious type of recall.
Food and Drug Administration (FDA). Stryker Neurovascular Recalls Trevo XP ProVue Retriever Due to Core Wire That May Break or Separate During Use [medical device recall]. November 9, 2020. Available at: click here. Accessed November 11, 2020.