# FDA recall Z-0292-2022

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

## Product

Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE	STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE	STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE	STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE	STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE	STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE	STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE	STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE	STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE	STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EJ	STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ	STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ	STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2314C103E		Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E		Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E		Stent Graft ESBF2314C103E Endur IIs BIF ESBF2814C103EE	STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE	STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ES

## Reason for recall

Due to, 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-0292-2022
- **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-0292-2022

## Citation

> AI Analytics. FDA recall Z-0292-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0292-2022. Source: US FDA. Licensed CC0.

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