10.12.20
By Mike Smith
The FDA released details of the Class 1 recall of the Stryker Neurovascular Trevo XP ProVue Retriever because the core wire of the device can break and separate from the body of the device during surgery.
Stryker initiated the recall on September 21, according to the FDA. All told, 1,258 at-risk Trevo XP ProVue Retriever devices were being recalled. The company took this action in response to numerous incidents that lead to 11 reports of injury and one death.
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. However, according to the FDA, the device proved unsafe and had to be recalled because “there is a risk 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.”