# FDA recall Z-0657-2022

> **Medtronic Vascular, Inc.** · Class II · device recall initiated 2021-12-21.

## Product

Endurant, Endurant II and Endurant IIs Stent Graft System:    Medtronic Endurant Stent Graft System Model/REF  ENBF2313C120EE;  ENBF2313C120EE;  ENBF2313C145EE;  ENBF2313C170EE;  ENBF2316C120EE;  ENBF2316C145EE;  ENBF2316C170EE;  ENBF2513C120EE;  ENBF2513C145EE;  ENBF2513C170EE;  ENBF2516C120EE;  ENBF2516C145EE;  ENBF2516C170EE;  ENBF2813C145EE;  ENBF2813C170EE;  ENBF2816C120EE;  ENBF2816C145EE;  ENBF2816C170EE;  ENBF3216C120EE;  ENBF3216C145EE;  ENBF3216C170EE;  ENBF3616C145EE;  ENBF3616C170EE;  ENCF2323C45EE;  ENCF2525C45EE;  ENCF2828C45EE;  ENCF3232C45EE;  ENCF3636C45EE;  ENTF2323C70EE;  ENTF2525C70EE;  ENTF2828C70EE;    Medtronic Endurant II Stent Graft System Model/REF  ETBF2313C124E;  ETBF2313C124EE;  ETBF2313C145EE;  ETBF2313C145EJ;  ETBF2313C166EE;  ETBF2313C166EJ;  ETBF2316C124E;  ETBF2316C124EE;  ETBF2316C124EJ;  ETBF2316C145E;  ETBF2316C145EE;  ETBF2316C145EJ;  ETBF2316C166E;  ETBF2316C166EE;  ETBF2316C166EJ;  ETBF2513C124E;  ETBF2513C124EE;  ETBF2513C124EJ;  ETBF2513C145EE;

## Reason for recall

Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable.

## Distribution

Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS,KY, LA, MA, MD, ME, MI, MN, MOMS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Argentina, Australia, Austria, Belgium, Bosnia And Herzegovina, Brazil, Bulgaria, Canada, Canary Islands, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic Of, Kosovo, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, North Macedonia, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Afri

## Key facts

- **Recall number:** Z-0657-2022
- **Recalling firm:** Medtronic Vascular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-12-21
- **Report date:** 2022-03-02

- **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-0657-2022

## Citation

> AI Analytics. FDA recall Z-0657-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0657-2022. Source: US FDA. Licensed CC0.

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