# FDA recall Z-0686-2018

> **Boston Scientific Corporation** · Class II · device recall initiated 2017-11-06.

## Product

Innova Self-Expanding Stent System, 180mm.  Labeled with Material Number and description as follows:      Product Usage:  The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) with reference vessel diameters from 4.0 mm to 7.0 mm and lesion lengths up to 190 mm.      a. H74939180051870 (Material Description Innova-EU 5 x 180 x 75);    b. H74939180061870 (Material Description Innova-EU 6 x 180 x 75);    c. H74939180071870 (Material Description Innova-EU 7 x 180 x 75);    d. H74939180071870 (Material Description Innova-EU 8 x 180 x 75);    e. H74939181051830 (Material Description Innova-EU 5 x 180 x 130);    f. H74939181061830 (Material Description Innova-EU 6 x 180 x 130);    g. H74939181071830 (Material Description Innova-EU 7 x 180 x 130);    h. H74939181081830 (Material Description Innova-EU 8 x 180 x 13

## Reason for recall

Stent possibly unable to be fully released from the delivery system.

## Distribution

Worldwide Distribution - US Nationwide     Distributed domestically to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV.      Distributed internationally to Canada

## Key facts

- **Recall number:** Z-0686-2018
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2017-11-06
- **Report date:** 2018-02-28

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0686-2018

## Citation

> AI Analytics. FDA recall Z-0686-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-0686-2018. Source: US FDA. Licensed CC0.

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