FDA-Device2020-04-01Class I
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Hazard
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.
Sold states
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, Norway, Paraguay, Poland, Qatar, Russian Federation, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Viet Nam
Affected count
1050
Manufactured in
9775 Toledo Way, N/A, Irvine, CA, United States
Products
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1527-2020Don't want to check this manually?
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