Medtronic is recalling the MindFrame Capture LP revascularization device used to during procedures to treat strokes because the delivery wire may break or separate during use, leaving the clot retriever inside the patient’s bloodstream. 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.
The MindFrame Capture LP revascularization device used to restore blood flow or remove blood clots within in a blood vessel in the brain during an acute ischemic stoke in patients ineligible for or who fail intravenous plasminogen activator (IV t-PA) therapy. The recall affects 529 devices in the U.S., which were distributed to medical facilities nationwide from March 18, 2016, to Jan. 17, 2018. Nine product lots are affected.
Medtronic notified its customers with affected revascularization devices asking them to remove any affected MindFrame Capture LP Revascularization devices from their inventory, quarantine them, and return them to Medtronic. The company also recommended that they follow up with patients closely and consider anti-platelet therapy or repeating imaging on the patient.
Any adverse events or quality issues regarding these devices should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
This recall is classified as a Class I recall by the FDA, which is the most serious type of recall, and indicates that use of these devices may cause serious injuries or death.
Source: FDA Recall Notice