# FDA recall Z-0291-2022

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

## Product

Endurant II Stent Graft System REF/Description: ETBF2513C145EE	STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE	STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE	STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE	STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE	STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE	STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE	STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE	STENT GRAFT ETBF2820C166EE ENDUR II BIF ETCF2828C49EE		STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE		STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE		STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETUF2514C102EE	STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE	STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE	STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE	STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE	STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE	STENT GRAFT ETUF2514C102EE ENDUR II AUI ETBF2313C124EE	ST

## 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-0291-2022
- **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-0291-2022

## Citation

> AI Analytics. FDA recall Z-0291-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0291-2022. Source: US FDA. Licensed CC0.

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