[Posted 05/18/2018]
AUDIENCE: Cardiology, Risk Manager, Surgery
ISSUE: 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.
Recalled Product: The MindFrame Capture LP revascularization device
Product Lot Numbers: 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018
Distribution Dates: March 18, 2016 to January 17, 2018
Manufacturing Dates: February 3, 2016 to January 14, 2018
Devices Recalled in the U.S.: 529 nationwide
BACKGROUND: The MindFrame Capture LP revascularization device is intended to restore blood flow or remove blood clots within a blood vessel in the brain during an acute ischemic stroke in patients who are ineligible for or fail intravenous tissue plasminogen activator (IV t-PA) therapy
RECOMMENDATION: On April 4, 2018, Medtronic followed up with their customers with another Urgent Medical Device Recall notice regarding patient management. The notice recommended health care providers to:
Review the notification and distribute the information to all appropriate personnel
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Follow up with the patient closely
Complete and return the acknowledgement and receipt form to Medtronic
Customers with questions may contact Medtronic Quality Assurance by email at Rs.nvcomplaints@medtronic.com or by phone at 1(800) 633-8766.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
[05/18/2018 - Medical Device Recall Communication - FDA]
