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Micro Therapeutics Inc, Dba Ev3 Neurovascular recalls ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
Recalled April 1, 2020 · FDA recall Z-1527-2020 · Micro Therapeutics Inc,
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. · FDA Class I
Units
1050
Sold at
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
Description
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.
Product
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
Manufacturer(s)
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →