Medtronic Recalls Neurovascular Products

FDA says that Medtronic has recalled four of its neurovascular products due to potential separation and detachment of polytetrafluoroethylene (PTFE) coating. The FDA notice says this is a Class 1 recall. The affected products are pipeline embolization device, alligator retrieval device, marathon flow directed micro catheter, and X-celerator hydrophilic exchange guidewire. They were manufactured between 7/2014 and 9/2016, and distributed between 10/2014 and 8/5/15, the notice says.

The agency notice says the devices are designed to be used together in treating cerebral aneurysms. It says that if the PTFE separates from the device, it could enter the patient’s blood stream and lead to downstream blood clots and/or irreversible brain injuries, including ischemic stroke, thrombosis, and hemorrhage, potentially resulting in serious adverse health consequences, including death.