Covidien, a global healthcare product manufacturer, has issued a recall for certain lots of its Pipeline Embolization Device and Alligator Retrieval Device.
What Is The Covidien Pipeline Embolization Device and Alligator Retrieval Device?
The Pipeline Embolization Device (PED) is the first and only flow diversion device approved by the FDA. The Pipeline Device is designed to treat aneurysms that were once considered inoperable.
Flow diversion is a technique used to treat large or giant wide-necked brain aneurysms. The Pipeline Device is placed in the parent blood vessel rather than the aneurysm sac.
The device reconstructs the parent artery by providing a flexible yet scaffolding across the aneurysm neck and restores original natural blood circulation while providing permanent long term occlusion.
During the procedure the Pipeline Device is implanted across the aneurysm neck, which slows the flow of blood into the aneurysm allowing the diseased vessel to heal.
The Alligator Retrieval Device is intended for use in the peripheral vasculature and neuro-vasculature for foreign body retrieval.
Foreign body retrieval involves the removal of potentially dangerous objects or substances in the body that have been introduced from the outside.
Covidien notified customers of the voluntary recall by letter earlier this month, and is arranging for replacement of the recalled products.
A total of 32 Pipeline Embolization Devices and 621 Alligator Retrieval Devices are affected by this recall. The reason Covidien issued a recall to these products is because the polytetrafluoroethylene (PTFE) that coats the devices could delaminate and detach from the devices.
The PTFE coating is used to reduce friction between devices and ease navigation through the vasculature.
Delamination of the PTFE coating could potentially lead to blood clots in the blood vessels of the brain with the risk of stroke or death.
The recall involves the PED sold in the U.S, Australia, France, Germany and United Kingdom and the Alligator Retrieval Device sold in the U.S., Australia, Canada, Europe and Latin America.
The FDA has classified this as a Class I recall and encourages healthcare professionals and patients to report any adverse events or side effects related to the use of these products to the FDA MedWatch Safety Information and Adverse Event Reporting Program.