Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and description as follows: Product Usage: The I

FDA device recall Z-0686-2018 · posted 2018-02-22 · Open, Classified

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

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

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

NIP

Quantity affected

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, O

Date initiated

2017-11-06

Date posted

2018-02-22

Location

Maple Grove, MN