Medtronic recalls several devices, FDA notified
The recall also includes the stylet containing UltraFlow flow directed micro catheters and Marathon flow directed micro catheters.
These products are produced, marketed and sold by Medtronic's Neurovascular business, which is part of the Brain Therapies division in the company's Restorative Therapies Group.
This voluntary recall is being conducted due to the potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on parts of these devices.
Should the PTFE separate from the delivery wire or stylets, PTFE particulate could enter the blood stream of the patient. PTFE in the blood stream, based on the size and quantity, could lead to a thromboembolic event.
Medtronic initiated customer communication of the recall by letter on October 5, 2016, and is requesting customers to quarantine all affected product that remain in the inventory and return to Medtronic.
The U.S. Food and Drug Administration (FDA) and other regulatory bodies also have been notified.
At the initiation of this recall, 84,278 units potentially affected by this recall had been distributed worldwide. The products were manufactured from July 2014 to September 2016.
Medtronic is taking this voluntary action as a precaution and has received no reports of patient injuries to date related to this issue. ■