# FDA recall Z-2136-2021

> **Medtronic Vascular, Inc.** · Class II · device recall initiated 2021-06-07.

## Product

Medtronic Endurant IIs Stent Graft System    Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E.       Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.

## Reason for recall

During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.

## Distribution

U.S.: GA, MA, MD, NY, SC, TX, WA, and WV  O.U.S.: Argentina, Australia, Germany, Greece, Israel, Italy, Netherlands, Poland, South Africa, Spain, Switzerland and United Kingdom.

## Key facts

- **Recall number:** Z-2136-2021
- **Recalling firm:** Medtronic Vascular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-06-07
- **Report date:** 2021-08-04

- **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-2136-2021

## Citation

> AI Analytics. FDA recall Z-2136-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2136-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*