ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
Reported: April 1, 2020 Initiated: February 14, 2020 #Z-1527-2020
Product Description
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
Reason for Recall
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.
Details
- Recalling Firm
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Units Affected
- 1050
- Distribution
- 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
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.. Recalled by Micro Therapeutics Inc, Dba Ev3 Neurovascular. Units affected: 1050.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 1, 2020. Severity: Critical. Recall number: Z-1527-2020.
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