Micro Therapeutics Inc, Dba Ev3 Neurovascular recalls ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.

Recall date

February 14, 2020

Source

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

Recall number

Z-1528-2020

FDA classification

Class I

Brand / firm

Micro Therapeutics Inc, Dba Ev3 Neurovascular

Sold / distributed

Worldwide distribution. US nationwide, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Jordan, Kazakhstan, Korea, Lebanon, Mexico, Netherlands, Norw…

Why it was recalled

Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to this issue.

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

ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.