Micro Therapeutics Inc, Dba Ev3 Neurovascular recalls Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body remov…

Recall date

October 5, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0308-2017

FDA classification

Class I

Brand / firm

Micro Therapeutics Inc, Dba Ev3 Neurovascular

Sold / distributed

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kon…

Why it was recalled

Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04 FA-88810-30V06 FA-88810-40V04 FA-88810-40V06 FA-88810-50V04 FA-88810-50V06