FDA designates recall of clot-removal device as Class 1

The FDA has designated Medtronic’s product recall of a revascularization device used to treat patients with acute ischemic stroke as a Class 1 recall, the most serious kind. The recall affects 529 devices manufactured and distributed between March 18, 2016 and January 14, 2018.

The delivery wire in the device (MindFrame Capture LP, Medtronic) may break or separate during use in patients with acute ischemic stroke who are either ineligible for or fail IV tissue plasminogen activator therapy, according to a MedWatch report from the FDA. This may lead to further complications such as additional blockage of blood vessels, bleeding, death or more severe stroke symptoms as a result of the clot retriever in the bloodstream or attempts to retrieve the device, according to the agency.

Medtronic distributed a notice to customers on February 26, 2018, alerting them to remove any affected devices from inventory and return them to the company. Another notice regarding patient management was sent on April 4, 2018. In the notice, customers were instructed to consider antiplatelet therapy or repeat imaging while closely monitoring the patient.

The lot numbers affected are 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017 and 300018.