# FDA recall Z-0188-2018

> **Medtronic Inc.** · Class II · device recall initiated 2017-11-03.

## Product

Everflex Self-Expanding Peripheral Stent with Entrust Delivery System   Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 - 7.5 mm.

## Reason for recall

Stent length on the label may not match the length of the stent itself.

## Distribution

Nationwide Distribution to AZ, CA, GA, IA, IL, KY, MA, NC, NE, SC, TN, VA

## Key facts

- **Recall number:** Z-0188-2018
- **Recalling firm:** Medtronic Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-03
- **Report date:** 2017-12-06
- **Termination date:** 2020-09-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plymouth, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0188-2018

## Citation

> AI Analytics. FDA recall Z-0188-2018. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0188-2018. Source: US FDA. Licensed CC0.

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