# FDA recall Z-0290-2022

> **Medtronic Vascular, Inc.** · Class II · device recall initiated 2021-10-15.

## Product

Endurant Stent Graft System  REF/Description:  ENTF2525C70EE	STENT GRAFT ENTF2525C70EE ENDURANT TUBE

## Reason for recall

During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube

## Distribution

Worldwide distribution - U.S. Nationwide distribution in the states of CA, FL, GA, MN, MO, NC, NJ, NM, NV, NY, PA, SC, TN, TX, VA, and WV. The countries of Austria, Belgium, Bulgaria, China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Jordan, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Qatar, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

## Key facts

- **Recall number:** Z-0290-2022
- **Recalling firm:** Medtronic Vascular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-10-15
- **Report date:** 2021-12-01

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0290-2022

## Citation

> AI Analytics. FDA recall Z-0290-2022. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0290-2022. Source: US FDA. Licensed CC0.

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