The FDA had issued a Class I recall of the MindFrame Capture LP device.
The US Food and Drug Administration (FDA) has issued a Class I recall of the MindFrame Capture LP revascularization device, from Medtronic. The Class I indication is reserved for the most serious types of recalls, for products that could cause serious injuries or death.
The device, which during an acute ischemic stroke is intended to restore blood flow or remove blood clots within a blood vessel for patients who are ineligible for intravenous plasminogen activator (IV t-PA) therapy, has been recalled by Medtronic due to a risk of the delivery wire breaking or separating during use.
Because of this issue, the clot receiver could be left inside a patient’s bloodstream — leading to potential complications in attempts to retrieve it. These complications could include bleeding, additional blockage of blood vessels, additional stroke symptoms, or even death, according to the FDA.
The decision follows a February 26 Urgent Medical Device Recall Notice sent by Medtronic to all its affect customers. The notice asked patients to remove any of the devices from inventory and quarantine them, and requested they also return damaged products to the company. Another notice from the company last month recommended health care providers consider anti-platelet therapy for patients who had used the devices, provide repeating imaging on said patients, and complete and return an acknowledgement and receipt form to Medtronic.
The devices were manufactured from February 3, 2016 to January 14, 2018. According to the FDA, 529 devices have been recalled in the US.
Medtronic, a leading developer of healthcare devices, was given the FDA green light for the Riptide Aspiration System, a product that can restore blood flow to the brain during acute ischemic stroke, this January. The device was designed to retrieve thrombus through a company-designed arc catheter, which inserted into patients via an incision in the leg and up to the blocked artery.