Medtronic MindFrame Capture LP Revascularization Device recalled for a Dangerous and potentially Deadly Defect
Meyers & Flowers is warning stroke patients and their families about a serious, Class 1 FDA recall for Medtronic's MindFrame Capture L Revascularization Device for a potentially lethal defect.
The MindFrameCapture LP Revascularization Device was developed to treat patients who have had an acute ischemic stroke and is used to remove a blood clot in a blood vessel or restore fails to respond to intravenous tissue plasminogen activator (IV t-PA) therapy.
During a mechanical thrombectomy or clot removal procedure, a thin wire tube is inserted into an artery and threaded up into the brain until it reaches the blocked vessel or clot. The wire mesh stent retriever expands and grabs the clot removing it as the device is pulled out of the artery and blood flow is restored to the brain.
According to the FDA, Medtronic is recalling the MindFrame Capture LP revascularization device because there is a risk of the delivery wire breaking or separating during use. The clot retriever could be left inside the patient's bloodstream, and this or the attempts made to retrieve the device can lead to further complications including bleeding, additional blockage of blood vessels, more severe stroke symptoms, or death. Read more about the recall here.
Approximately 800,000 people in the U.S. have strokes each year making it one of the leading causes of long-term disability and deaths according to the American Stroke Association. Some 87 percent of strokes are classified as ischemic strokes and are due to blockages in the blood vessels or blood clots. Thousa ds of clot retrieval procedures are done each year to help stroke victims.
Currently, the total number of Medtronic clot retrieval devices recalled in the U.S. has reached 529, according to the FDA. Recalled product lot numbers include the following: 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017 and 300018. The defective devices were manufactured between Feb. 3, 2016, and Jan. 14, 2018; and were distributed between March 18, 2016, and Jan. 17, 2018.
Meyers & Flowers has spent more than two decades fighting to protect the rights of those injured by defective medical devices such as the Medtronic MindFrame Capture LP Revascularization Device. If you or a family member have been harmed by this device contact us to explore your legal recourse options at 877-221-2511 or request a Free Case Evaluation Online.