Boston Scientific Corporation recalls Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: Product Usage:

Recalled February 28, 2018 · FDA recall Z-0685-2018 · Boston Scientific

Hazard

Stent possibly unable to be fully released from the delivery system. · FDA Class II

Units

22,916 units total

Sold at

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

Description

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

Product

Innova Self-Expanding Stent System, 200 mm. 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. H74939293052030 (Material Description Innova 5 x 200 x 130); b. H74939293052070 (Material Description Innova 5 x 200 x 75); c. H74939293062030 (Material Description Innova 6 x 200 x 130); d. H74939293062070 (Material Description Innova 6 x 200 x 75); e. H74939293072030 (Material Description Innova 7 x 200 x 130); f. H74939293072070 (Material Description Innova 7 x 200 x 75); g. H74939293082030 (Material Description Innova 8 x 200 x 130); h. H74939293082070 (Material Description Innova 8 x 200 x 75)

Manufacturer(s)

Boston Scientific Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →