Medtronic MindFrame Capture LP Revascularization Device Wire May Break, Separate During Use: Recall

Federal health officials indicate that certain recalled Medtronic revascularization devices, which are used to remove blood clots within the brain’s blood vessels, have delivery wires that may break or separate during surgical procedures, posing a risk of serious adverse health consequences or death. 

A class 1 Medtronic Mindframe Capture LP recall was announced by the FDA on May 18, after determining the revascularization device wires may break or separate during use, resulting in a risk of bleeding events or further blockages.

The recall involves revascularization devices intended to restore blood flow or remove blood clots within a blood vessel in the brain during ischemic stroke events for patients unable to receive intravenous tissue plasminogen activator therapy.

The Class I designation indicates that the product causes a situation which there is a reasonable probability that the use or exposure could cause serious adverse health consequences or death.

The FDA assigned the highest classification to the recall because the clot retriever could be left inside the patients’ bloodstream, and cause further blockages. Attempts to remove the detached delivery wire could cause further complications including bleeding, blocked blood vessels, more severe stroke symptoms, or death.

The recalled MindFrame Capture LP revascularization devices were manufactured from February 3, 2016 through January 14, 2018 by Medtronic Equipment Company of Minneapolis, Minnesota. Recalled devices are marked with Lot numbers 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018. The devices were distributed to hospitals and medical facilities nationwide from March 18, 2016 through January 17, 2018.

According to the FDA recall notice, approximately 529 recall devices were distributed for sale throughout the United States.

Medtronic released an Urgent Medical Device Recall Notice to all of its affected customers describing the issue and instructing customers to remove any of the devices from use and quarantine them.

Customers with additional questions concerning the recall should contact Medtronic at 1-800-633-8766 or visit them online at Rs.nvcomplaints@medtronic.com.