Irish medical technology firm Medtronic has recalled certain lots of its Pipeline embolization device, Alligator retrieval device and X-Celerator hydrophilic guidewire.
The recall also includes stylet containing UltraFlow directed micro catheters and Marathon flow directed micro catheters.
Medtronic is recalling the products due to the potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on parts of these devices.
PTFE particulate is expected to enter the blood stream of the patient, if it is not separated from the delivery wire or stylets.
Based on the size and quantity, PTFE in the blood stream may lead to a thromboembolic event.
Medtronic said that around 84,278 units potentially affected by this recall had been distributed worldwide.
The products have been manufactured from July 2014 to September 2016.
Pipeline embolization will be used for the endovascular treatment of adults, aged 22 years and older, with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.
Alligator retrieval device has been developed for use in the peripheral and neuro-vasculature for foreign body retrieval.
X-Celerator hydrophilic guidewire is intended for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.
Medtronic said that it is taking this voluntary action as a precaution and has received no reports of patient injuries to date related to this issue.