Following reports of numerous injuries and one death, Stryker recalled its Trevo XP ProVue Retriever. The Trevo XP ProVue Retriever is intended to treat acute ischemic strokes. An acute ischemic stroke is caused when the blood flow through a blood vessel (i.e., an artery, vein, or capillary) in the brain becomes wholly or partially blocked by a blood clot or other bodily substance. The Trevo XP ProVue Retriever is designed to restore blood flow or remove blood clots from the blocked blood vessel. When operating as intended, the net like structure of the Trevo XP ProVue Retriever is delivered into a patient’s vessel, allowing physicians to capture and then retrieve the clot. Unfortunately, there are numerous reports that this device is doing more harm than good.
On October 21, 2020, the FDA announced the recall of Stryker’s Trevo XP ProVue Retriever device. The recall notice indicates that at that time, there were reports of 11 injuries and one death. According to the recall notice, pieces of the Trevo XP ProVue Retriever have broken or separated during use. When this happens, parts of the device can be left inside the patient’s blood vessel. This can cause serious injuries, including additional blockage of the vessel, disability, and death. Accordingly, the FDA has classified this recall as a Class 1 recall, the most serious type of recall.
Stryker reports that on September 21, 2020, it sent a notice to all affected customers advising them to, among other things, return any non-used products. According to the recall notice, the number of recalled devices in the United States is 1,258 and they were distributed between September 18, 2019 to July 7, 2020.
If you or a loved one suffered injuries you believe were caused by a Trevo XP ProVue Retriever device, contact the nationally recognized medical device attorneys in Burg Simpson’s Cincinnati, Ohio office today. They can be reached by phone at (513)852-5600 or through their website.