EV3 Pipeline Flex Embolization Device with Flex Shield Technology
Reported: September 15, 2021 Initiated: July 13, 2021 #Z-2403-2021
Product Description
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
Reason for Recall
Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.
Details
- Recalling Firm
- Micro Therapeutics Inc,
- Units Affected
- 16,169 total devices for all model/products
- Distribution
- U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV O.U.S.: Argentina, Brazil Canada, Chile, Colombia, Ecuador, Mexico, Peru, Austria, Belgium, Canary Island, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Kazakhstan, Latvia, Macedonia, Netherlands, Norway, Poland, Russian Federation, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom, Brunei Darussalam, Egypt, Israel, Jordan, Lebanon, Qatar, Saudi Arabia, Syrian Arab Republic, United Arab Emirates, South Africa, Tunisia, Reunion, China, Hong Kong, Macao, Singapore, Taiwan, Australia, New Zealand, Bangladesh, India, Pakistan, Indonesia, Malaysia, Thailand, Vietnam, Japan, and Republic of Korea.
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
EV3 Pipeline Flex Embolization Device with Flex Shield Technology. Recalled by Micro Therapeutics Inc,. Units affected: 16,169 total devices for all model/products.
Why was this product recalled? ▼
Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 15, 2021. Severity: Critical. Recall number: Z-2403-2021.
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