Recall Z-0685-2018 ยท NIP Stent, Superficial Femoral Artery
Boston Scientific Corporation
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 t
| Date | Feb 22, 2018 (initiated Nov 6, 2017) |
| Status | Open, Classified |
| Reason | Stent possibly unable to be fully released from the delivery system. |
| Root cause | Nonconforming Material/Component |
| Action | Boston Scientific sent an Urgent Medical Device letter dated November 6, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers\ were instructed to immediately discontinue use of the product and remove all affected products from inventory, complete and return the Verification Form, return affected products and provide the notification to any healthcare professionals affected. |
| Quantity | 22,916 units total |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.