# FDA recall Z-1527-2020

> **Micro Therapeutics Inc, Dba Ev3 Neurovascular** · Class I · device recall initiated 2020-02-14.

## Product

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.

## 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

## Key facts

- **Recall number:** Z-1527-2020
- **Recalling firm:** Micro Therapeutics Inc, Dba Ev3 Neurovascular
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-14
- **Report date:** 2020-04-01
- **Termination date:** 2024-06-12

- **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-1527-2020

## Citation

> AI Analytics. FDA recall Z-1527-2020. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-1527-2020. Source: US FDA. Licensed CC0.

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