# FDA recall Z-2403-2021

> **Micro Therapeutics Inc,** · Class I · device recall initiated 2021-07-13.

## Product

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.

## 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.

## Key facts

- **Recall number:** Z-2403-2021
- **Recalling firm:** Micro Therapeutics Inc,
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-07-13
- **Report date:** 2021-09-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2403-2021

## Citation

> AI Analytics. FDA recall Z-2403-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2403-2021. Source: US FDA. Licensed CC0.

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